Active, not recruitingNCT01586910SURTAVIUpdated Jun 24, 2026Results posted

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

An interventional study of Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) in Severe Aortic Stenosis, sponsored by Medtronic Cardiovascular. Active, not recruiting at 86 sites in 9 countries. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Medtronic Cardiovascular · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 1,746
Allocation: Randomized
Sex: All

Study summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Conditions studied

Severe Aortic Stenosis

Browse trials for

Aortic Valve Stenosis 985

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 1,746 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Medtronic Cardiovascular is the lead sponsor of 66 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and \<15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
Heart Team unanimously agree on treatment proposal and eligibility for randomization* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
Subject has severe aortic stenosis presenting with;
1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND
2. Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%] or velocity ratio \< 0.25;
Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion criteria

Exclusion Criteria:

Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
Ongoing sepsis, including active endocarditis;
Any condition considered a contraindication to extracorporeal assistance;
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization*;
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
Recent (within 6 months of randomization*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
Subject refuses a blood transfusion;
Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
Currently participating in an investigational drug or another device trial (excluding registries);
Evidence of an acute myocardial infarction ≤30 days before the index procedure;
Need for emergency surgery for any reason;
True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
Extensive mediastinal radiation;
Liver failure (Child-C);
Reduced ventricular function with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram;
Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min;
Pulmonary Hypertension (systolic pressure> 80mmHg);
Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc;
Frailty assessments identify:
1. Subject is \< 80 years of age and three or more of the following apply
2. Subject is ≥ 80 years of age and two or more of the following apply
  - Wheelchair bound
  - Resides in an institutional care facility (e.g., nursing home, skilled care center)
  - Body Mass Index \< 20 kg/m2
  - Grip Strength \< 16 kg
  - Katz Index Score ≤ 4
  - Albumin \< 3.5 g/dL;
Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)

Note: Additional anatomical and vascular exclusion criteria may apply.

Note: * For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,746 participants (actual)

Study arms

Experimental
Medtronic CoreValve® System TAVI
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) · Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Active comparator
SAVR
Surgical Aortic Valve Replacement (SAVR)
Procedure: Surgical Aortic Valve Replacement (SAVR)

Interventions

DeviceMedtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
ProcedureSurgical Aortic Valve Replacement (SAVR)
DeviceMedtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

What researchers measure

Primary outcomes

All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.
Time frame: 24 months

Secondary outcomes

Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Individual MACCE Components
MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Major Adverse Events (MAE)
Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
Time frame: 30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Change in NYHA Class From Baseline
Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time frame: Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Change in Distance Walked During 6-minute Walk Test (6MWT)
Change in distance walked during 6MWT from baseline
Time frame: From baseline to 30 days, baseline to 12 months, and baseline to 24 months
Ratio of Days Alive Out of Hospital Versus Total Days Alive
Time frame: 12 and 24 months
Quality of Life (QoL) Change From Baseline
QoL summary score change from baseline using the following measures: * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance
Using the following measure: -Transvalvular mean gradient
Time frame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Effective Orifice Area as an Assessment of Prosthetic Valve Performance
Using the following measure: -Effective Orifice Area (cm\^2)
Time frame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Time frame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Percentage of Participants With Aortic Valve Disease Related Hospitalizations
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Percentage of Participants With Stroke and TIAs
Strokes (of any severity) and Transient Ischemic Attacks (TIAs)
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Peri-procedural Neurological Injury
Neurological injury (stroke, TIA, or encephalopathy)
Time frame: discharge or 7 days post index procedure (whichever occurred first)
Index Procedure Related Major Adverse Events (MAEs)
Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.
Time frame: Procedure through 30 day visit
Length of Index Procedure Hospital Stay
Time frame: Number of days from admission to discharge (expected average of 7 days)
Presence of Atrial Fibrillation
Time frame: post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Device Success (Medtronic CoreValve® System Subjects Only)
* Absence of procedural mortality * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Time frame: Number of days from admission to discharge (expected average of 7 days)
Procedural Success (Medtronic CoreValve® System Subjects Only)
Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: Number of days from admission to discharge (expected average of 7 days)
Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)
Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered PVD defined as: * Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA \<1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI \<0. 35 m/s) OR * moderate or severe total AR
Time frame: 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Early Safety Endpoint
Percentage of participants with VARC II early safety composite at 30 days
Time frame: 30 Days
Percentage of Participants With Clinical Efficacy (After 30 Days)
Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.
Time frame: 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Percentage of Participants With Time-Related Safety
The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI \<0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.
Resheath and Recapture Success (Evolut R Only)
The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.
Time frame: Procedure

Results

Posted Sep 17, 2019

Participant flow

Participant flow — Overall Study
Milestone	Medtronic CoreValve® System TAVI	SAVR
Started	879	867
Completed	864	796
Not completed	15	71
Withdrew: Death	4	4
Withdrew: Withdrawal by subject	6	43
Withdrew: Physician withdrew subject	5	24

Outcome measures

PrimaryAll-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability

All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.

Time frame:: 24 months
Reported as:: Median · Percentage of Participants

All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
Percentage of Participants	Medtronic CoreValve® System TAVI	SAVR
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability	12.6 (10.2 to 15.3)	14.0 (11.4 to 17.0)

Statistical analysis

Medtronic CoreValve® System TAVI vs SAVR · Bayesian · Posterior median of the difference: -1.495% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.

SecondaryPercentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Time frame:: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of participants

Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
30 days	5.7	7.3
6 months	9.5	10.7
12 months	13.0	13.0
18 months	15.6	14.8
24 months	18.5	18.2

SecondaryPercentage of Participants With Individual MACCE Components

Time frame:: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of participants

Percentage of Participants With Individual MACCE Components
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
30 day All Cause Mortality	2.1	1.6
30 day MI	0.8	0.9
30 day Stroke	3.3	5.4
30 day Reintervention	0.8	0.1
6 month All Cause Mortality	4.2	4.7
6 month MI	1.2	1.4
6 month Stroke	4.6	6.6
6 month Reintervention	1.8	0.3
12 month All Cause Mortality	6.5	6.7
12 month MI	1.9	1.4
12 month Stroke	5.2	6.9
12 month Reintervention	2.0	0.5
18 month All Cause Mortality	8.5	7.9
18 month MI	2.2	1.8
18 month Stroke	5.7	7.5
18 month Reintervention	2.4	0.5
24 month All Cause Mortality	11.5	10.5
24 month MI	2.7	2.2
24 month Stroke	6.0	8.5
24 month Reintervention	2.4	0.5

SecondaryPercentage of Participants With Major Adverse Events (MAE)

Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.

Time frame:: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of participants

Percentage of Participants With Major Adverse Events (MAE)
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
30 days	23.7	30.3
6 months	28.5	33.6
12 months	33.0	35.8
18 months	36.6	38.4
24 months	40.0	41.8

SecondaryPercentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation

Time frame:: 30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of participants

Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
30 days	25.6	6.5
6 months	27.2	7.6
12 months	28.3	8.6
18 months	30.1	9.2
24 months	30.9	9.8

SecondaryChange in NYHA Class From Baseline

Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Time frame:: Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Mean · units on a scale

Change in NYHA Class From Baseline
units on a scale	Medtronic CoreValve® System TAVI	SAVR
30 day	-1.2 ± 0.8	-1.0 ± 0.9
6 month	-1.3 ± 0.8	-1.3 ± 0.8
12 month	-1.3 ± 0.8	-1.3 ± 0.8
18 month	-1.2 ± 0.8	-1.2 ± 0.8
24 month	-1.2 ± 0.8	-1.2 ± 0.8

SecondaryChange in Distance Walked During 6-minute Walk Test (6MWT)

Change in distance walked during 6MWT from baseline

Time frame:: From baseline to 30 days, baseline to 12 months, and baseline to 24 months
Reported as:: Mean · meters

Change in Distance Walked During 6-minute Walk Test (6MWT)
meters	Medtronic CoreValve® System TAVI	SAVR
30 days	35.4 ± 99.2	-14.4 ± 108.7
12 months	37.1 ± 103.5	17.8 ± 102.0
24 months	26.5 ± 115.4	11.7 ± 102.7

SecondaryRatio of Days Alive Out of Hospital Versus Total Days Alive

Time frame:: 12 and 24 months
Reported as:: Mean · ratio

Ratio of Days Alive Out of Hospital Versus Total Days Alive
ratio	Medtronic CoreValve® System TAVI	SAVR
12 months	0.96 ± 0.12	0.93 ± 0.15
24 months	0.96 ± 0.12	0.95 ± 0.15

SecondaryQuality of Life (QoL) Change From Baseline

QoL summary score change from baseline using the following measures: * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.

Time frame:: Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Mean · units on a scale

Quality of Life (QoL) Change From Baseline
units on a scale	Medtronic CoreValve® System TAVI	SAVR
30 day KCCQ- Overall	18.4 ± 22.8	5.9 ± 27.0
30 day KCCQ- Clinical	14.9 ± 21.2	4.0 ± 26.0
30 day SF-36-Physical	5.7 ± 10.4	-1.1 ± 11.0
30 day SF-36-Mental	2.6 ± 12.3	-0.6 ± 13.7
30 day EQ-5D	0.06 ± 0.18	-0.02 ± 0.21
3 month SF-36-Physical	7.4 ± 10.5	5.6 ± 10.5
3 month SF-36-Mental	4.6 ± 11.7	4.6 ± 12.6
3 month EQ-5D	0.06 ± 0.18	0.05 ± 0.18
6 month KCCQ- Overall	21.9 ± 22.3	21.3 ± 22.3
6 month KCCQ- Clinical	16.5 ± 21.5	15.9 ± 21.7
6 month SF-36-Physical	6.3 ± 10.3	6.3 ± 10.5
6 month SF-36-Mental	3.9 ± 11.4	3.6 ± 11.9
6 month EQ-5D	0.04 ± 0.18	0.05 ± 0.17
12 month KCCQ- Overall	20.6 ± 22.3	20.5 ± 22.2
12 month KCCQ- Clinical	15.1 ± 21.4	14.8 ± 21.6
12 month SF-36-Physical	5.2 ± 9.9	5.2 ± 10.2
12 month SF-36-Mental	4.0 ± 11.3	4.1 ± 12.0
12 month EQ-5D	0.04 ± 0.16	0.03 ± 0.18
18 month KCCQ- Overall	19.7 ± 21.5	20.2 ± 22.1
18 month KCCQ- Clinical	14.0 ± 20.7	14.0 ± 21.9
18 month SF-36-Physical	4.2 ± 10.4	4.3 ± 10.8
18 month SF-36-Mental	4.3 ± 11.1	3.8 ± 11.9
18 month EQ-5D	0.03 ± 0.17	0.03 ± 0.17
24 month KCCQ- Overall	18.9 ± 21.2	18.6 ± 22.9
24 month KCCQ- Clinical	12.7 ± 20.5	12.3 ± 22.5
24 month SF-36-Physical	3.9 ± 9.9	4.0 ± 10.8
24 month SF-36-Mental	3.6 ± 11.3	3.7 ± 12.2
24 month EQ-5D	0.02 ± 0.17	0.02 ± 0.19

SecondaryTransvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance

Using the following measure: -Transvalvular mean gradient

Time frame:: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Reported as:: Mean · mmHg

Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance
mmHg	Medtronic CoreValve® System TAVI	SAVR
discharge	8.82 ± 3.89	12.39 ± 5.71
6 months	8.28 ± 3.88	11.10 ± 4.72
12 months	8.34 ± 3.89	11.57 ± 5.16
24 months	8.20 ± 3.85	11.55 ± 5.43

SecondaryEffective Orifice Area as an Assessment of Prosthetic Valve Performance

Using the following measure: -Effective Orifice Area (cm\^2)

Time frame:: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Reported as:: Mean · cm^2

Effective Orifice Area as an Assessment of Prosthetic Valve Performance
cm^2	Medtronic CoreValve® System TAVI	SAVR
discharge EOA	2.13 ± 0.57	1.82 ± 0.63
6 months EOA	2.14 ± 0.61	1.80 ± 0.57
12 months EOA	2.13 ± 0.59	1.78 ± 0.59
24 months EOA	2.15 ± 0.63	1.77 ± 0.55

SecondaryDegree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance

Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)

Time frame:: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Reported as:: Number · Percentage of participants

Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
Percentage of participants	Medtronic CoreValve® System TAVI	SAVR
Discharge : Total Aortic Regurgitation- None	24.9	67.9
Discharge : Total Aortic Regurgitation- Trace	35.7	24.6
Discharge : Total Aortic Regurgitation- Mild	35.9	6.8
Discharge : Total Aortic Regurgitation- Moderate	3.2	0.7
Discharge : Total Aortic Regurgitation- Severe	0.2	0.0
6 months : Total Aortic Regurgitation- None	28.4	67.0
6 months : Total Aortic Regurgitation- Trace	32.2	24.3
6 months : Total Aortic Regurgitation- Mild	34.7	7.8
6 months : Total Aortic Regurgitation- Moderate	4.6	0.8
6 months : Total Aortic Regurgitation- Severe	0.1	0.2
12 months : Total Aortic Regurgitation- None	32.0	67.6
12 months : Total Aortic Regurgitation- Trace	28.8	23.5
12 months : Total Aortic Regurgitation- Mild	34.1	8.3
12 months : Total Aortic Regurgitation- Moderate	5.1	0.7
12 months : Total Aortic Regurgitation- Severe	0.0	0.0
24 months : Total Aortic Regurgitation- None	35.1	67.7
24 months : Total Aortic Regurgitation- Trace	30.5	25.3
24 months : Total Aortic Regurgitation- Mild	30.0	6.2
24 months : Total Aortic Regurgitation- Moderate	4.2	0.6
24 months : Total Aortic Regurgitation- Severe	0.2	0.2

SecondaryPercentage of Participants With Aortic Valve Disease Related Hospitalizations

Time frame:: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of particpants

Percentage of Participants With Aortic Valve Disease Related Hospitalizations
percentage of particpants	Medtronic CoreValve® System TAVI	SAVR
30 days	2.8	4.1
6 months	6.6	5.8
12 months	8.6	7.4
18 months	10.8	8.4
24 months	12.8	9.5

SecondaryPercentage of Participants With Cardiovascular Deaths and Valve-Related Deaths

Time frame:: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Reported as:: Number · percentage of participants

Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
30 day cardiovascular deaths	2.0	1.6
30 day valve related deaths	0.0	0.0
6 month cardiovascular deaths	3.2	3.9
6 month valve related deaths	0.0	0.1
12 month cardiovascular deaths	4.7	5.3
12 month valve related deaths	0.0	0.1
18 month cardiovascular deaths	5.9	6.1
18 month valve related deaths	0.0	0.1
24 month cardiovascular deaths	7.8	7.1
24 month valve related deaths	0.0	0.1

SecondaryPercentage of Participants With Stroke and TIAs

Strokes (of any severity) and Transient Ischemic Attacks (TIAs)

Time frame:: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of participants

Percentage of Participants With Stroke and TIAs
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
30 days	4.4	6.3
6 months	6.9	7.8
12 months	8.0	8.6
18 months	8.8	9.4
24 months	9.5	11.2

SecondaryPeri-procedural Neurological Injury

Neurological injury (stroke, TIA, or encephalopathy)

Time frame:: discharge or 7 days post index procedure (whichever occurred first)
Reported as:: Number · percentage of participants

Peri-procedural Neurological Injury
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
Peri-procedural Neurological Injury	4.8	12.3

SecondaryIndex Procedure Related Major Adverse Events (MAEs)

Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.

Time frame:: Procedure through 30 day visit
Reported as:: Number · percentage of participants

Index Procedure Related Major Adverse Events (MAEs)
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
Index Procedure Related Major Adverse Events (MAEs)	23.5	30.4

SecondaryLength of Index Procedure Hospital Stay

Time frame:: Number of days from admission to discharge (expected average of 7 days)
Reported as:: Mean · days

Length of Index Procedure Hospital Stay
days	Medtronic CoreValve® System TAVI	SAVR
Length of Index Procedure Hospital Stay	5.7 ± 4.9	9.8 ± 8.0

SecondaryPresence of Atrial Fibrillation

Time frame:: post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of participants

Presence of Atrial Fibrillation
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
post procedure	12.8	8.7
discharge	14.0	22.2
30 days	13.6	14.4
6 months	14.1	12.1
12 months	13.4	11.7
18 months	13.6	11.9
24 months	15.1	12.2

SecondaryDevice Success (Medtronic CoreValve® System Subjects Only)

* Absence of procedural mortality * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation)

Time frame:: Number of days from admission to discharge (expected average of 7 days)
Reported as:: Number · percentage of participants

Device Success (Medtronic CoreValve® System Subjects Only)
percentage of participants	Medtronic CoreValve® System TAVI
Device Success (Medtronic CoreValve® System Subjects Only)	77.0

SecondaryProcedural Success (Medtronic CoreValve® System Subjects Only)

Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)

Time frame:: Number of days from admission to discharge (expected average of 7 days)
Reported as:: Number · percentage of participants

Procedural Success (Medtronic CoreValve® System Subjects Only)
percentage of participants	Medtronic CoreValve® System TAVI
Procedural Success (Medtronic CoreValve® System Subjects Only)	74.7

SecondaryEvidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)

Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered PVD defined as: * Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA \<1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI \<0. 35 m/s) OR * moderate or severe total AR

Time frame:: 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Reported as:: Number · percentage of participants

Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
6 month	6.0	4.1
12 month	6.7	6.4
24 month	6.0	5.8

SecondaryPercentage of Participants With Early Safety Endpoint

Percentage of participants with VARC II early safety composite at 30 days

Time frame:: 30 Days
Reported as:: Number · percentage of participants

Percentage of Participants With Early Safety Endpoint
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
Percentage of Participants With Early Safety Endpoint	12.5	15.8

SecondaryPercentage of Participants With Clinical Efficacy (After 30 Days)

Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.

Time frame:: 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Reported as:: Number · percentage of participants

Percentage of Participants With Clinical Efficacy (After 30 Days)
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
6 months	12.8	9.9
12 months	23.5	21.0
18 months	26.3	22.6
24 months	33.9	33.0

SecondaryPercentage of Participants With Time-Related Safety

The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI \<0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.

Time frame:: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.
Reported as:: Number · percentage of participants

Percentage of Participants With Time-Related Safety
percentage of participants	Medtronic CoreValve® System TAVI	SAVR
30 days	28.8	61.7
6 months	38.5	69.6
12 months	45.1	72.1
18 months	42.1	67.8
24 months	53.0	77.3

SecondaryResheath and Recapture Success (Evolut R Only)

The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.

Time frame:: Procedure
Reported as:: Number · percentage of attempts

Resheath and Recapture Success (Evolut R Only)
percentage of attempts	Medtronic CoreValve® System TAVI
Resheath	100
Recapture	89.7
Resheath or Recapture	92.5

Adverse events

Collected over Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Medtronic CoreValve® System TAVI	98/864 (11.3%)	718/864 (83.1%)	803/864 (92.9%)
SAVR	80/796 (10.1%)	694/796 (87.2%)	754/796 (94.7%)

Most frequent serious events

Showing 10 of 842

Most frequent serious events
Event	Medtronic CoreValve® System TAVI	SAVR
ANAEMIABlood and lymphatic system disorders	102/864	203/796
ATRIAL FIBRILLATIONCardiac disorders	86/864	169/796
ATRIOVENTRICULAR BLOCK COMPLETECardiac disorders	157/864	44/796
PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders	38/864	102/796
HYPOTENSIONVascular disorders	51/864	87/796
HAEMORRHAGIC ANAEMIABlood and lymphatic system disorders	40/864	84/796
ACUTE KIDNEY INJURYRenal and urinary disorders	62/864	82/796
CARDIAC FAILURE CONGESTIVECardiac disorders	82/864	61/796
PNEUMONIAInfections and infestations	58/864	55/796
BUNDLE BRANCH BLOCK LEFTCardiac disorders	58/864	1/796

Most frequent other events

Showing 10 of 23

Most frequent other events
Event	Medtronic CoreValve® System TAVI	SAVR
BUNDLE BRANCH BLOCK LEFTCardiac disorders	258/864	55/796
ATRIAL FIBRILLATIONCardiac disorders	112/864	230/796
PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders	70/864	216/796
THROMBOCYTOPENIABlood and lymphatic system disorders	133/864	188/796
ATELECTASISRespiratory, thoracic and mediastinal disorders	62/864	151/796
LEUKOCYTOSISBlood and lymphatic system disorders	70/864	146/796
ACUTE KIDNEY INJURYRenal and urinary disorders	79/864	125/796
FLUID OVERLOADMetabolism and nutrition disorders	0/864	122/796
HYPERTENSIONVascular disorders	123/864	100/796
HYPERGLYCAEMIAMetabolism and nutrition disorders	53/864	102/796

Baseline characteristics

mITT

Age, Continuous
Age, Continuous(years)	Medtronic CoreValve® System TAVI	SAVR	Total
Mean	79.9 ± 6.2	79.7 ± 6.1	79.8 ± 6.2

Sex: Female, Male
Sex: Female, Male(Participants)	Medtronic CoreValve® System TAVI	SAVR	Total
Female	366	358	724
Male	498	438	936

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Medtronic CoreValve® System TAVI	SAVR	Total
Asian	7	6	13
Black/African American	18	21	39
Hispanic or Latino Ethnicity	18	23	41

NYHA Class
NYHA Class(Participants)	Medtronic CoreValve® System TAVI	SAVR	Total
I	0	0	0
II	344	333	677
III	472	411	883
IV	48	52	100

Body Surface Area
Body Surface Area(meters squared)	Medtronic CoreValve® System TAVI	SAVR	Total
Mean	1.9 ± 0.2	1.9 ± 0.2	1.9 ± 0.2

STS Score
STS Score(% risk of mortality)	Medtronic CoreValve® System TAVI	SAVR	Total
Mean	4.4 ± 1.5	4.5 ± 1.6	4.5 ± 1.6

Logistic EuroSCORE
Logistic EuroSCORE(percentage of predicted mortality)	Medtronic CoreValve® System TAVI	SAVR	Total
Mean	11.9 ± 7.6	11.6 ± 8.0	11.8 ± 7.8

Study locations

86 sites

Banner Good Samaritan Medical Center
Phoenix, Arizona 85006, United States
Cedars-Sinai Medical Center
Hollywood, California 90048, United States
Scripps Green Hospital
La Jolla, California 92037, United States
Keck Medical Center of USC
Los Angeles, California 90033, United States
El Camino Hospital
Mountain View, California 94040, United States
VA Palo Alto Health Care System
Palo Alto, California 94304, United States
Southern California Permenente Medical Group
Pasadena, California 91101, United States
Stanford University Medical Center
Stanford, California 94305, United States
Hartford Hospital
Hartford, Connecticut 06102, United States
Yale New Haven Hospital
New Haven, Connecticut 06520-8047, United States
Washington Hospital Center
Washington D.C., District of Columbia 20010, United States
Morton Plant Hospital
Clearwater, Florida 33756, United States
University of Miami
Coral Gables, Florida 33146, United States
Delray Medical Center
Delray Beach, Florida 33484, United States
Emory University
Atlanta, Georgia 30308, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia 30309, United States
The Queen's Medical Center
Honolulu, Hawaii 96813, United States
Loyola University of Chicago
Maywood, Illinois 60153, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana 46290, United States
Iowa Heart Center / Mercy Medical Center
West Des Moines, Iowa 50266, United States
University of Kansas Hospital
Kansas City, Kansas 66160, United States
Cardiovascular Institute of the South
Houma, Louisiana 70360, United States
The Johns Hopkins University
Baltimore, Maryland 21205, United States
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts 02215, United States
University of Michigan Health Systems
Ann Arbor, Michigan 48109-5864, United States
Detroit Medical Center
Detroit, Michigan 48201-2018, United States
Henry Ford
Detroit, Michigan 48202, United States
St. John Hospital & Medical Center
Detroit, Michigan 48236, United States
Spectrum Health Hospitals
Grand Rapids, Michigan 49503, United States
Abbott NW - MN Heart Institute Foundation
Minneapolis, Minnesota 55407, United States
Mayo Clinic - St. Mary's Hospital
Rochester, Minnesota 55905, United States
Saint Luke's Hospital/MAHI
Kansas City, Missouri 64111, United States
Alegent Creighton Health Research Center
Omaha, Nebraska 68124, United States
Cooper University Hospital
Camden, New Jersey 08103, United States
Morristown Medical Center
Morristown, New Jersey 07960, United States
North Shore University Hospital
Manhasset, New York 11030, United States
Winthrop University Hospital
Mineola, New York 11501, United States
New York University School of Medicine
New York, New York 10016, United States
Mount Sinai School of Medicine
New York, New York 10029, United States
Columbia University Medical Center
New York, New York 10032, United States
Lenox Hill Hospital
New York, New York 10075, United States
University of Rochester
Rochester, New York 14642, United States
St. Francis Hospital
Roslyn, New York 11576, United States
Carolinas HealthCare System
Charlotte, North Carolina 28203, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157, United States
Good Samaritan Hospital
Cincinnati, Ohio 45220, United States
University Hospitals Case Medical Center
Cleveland, Ohio 44106, United States
The Ohio State University
Columbus, Ohio 43210, United States
The OhioHealth Research Institute
Columbus, Ohio 43214, United States
Oklahoma Heart Institute
Oklahoma City, Oklahoma 73120, United States
Geisinger Medical Center
Danville, Pennsylvania 17822, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania 17043, United States
Stern Cardiovascular
Memphis, Tennessee 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232, United States
Baylor Heart and Vascular Hospital
Dallas, Texas 75226, United States
The Methodist DeBakey Heart & Vascular Center
Houston, Texas 77030, United States
The Heart Hospital - Baylor Plano
Plano, Texas 75093, United States
Intermountain Medical Center
Murray, Utah 84107, United States
University of Vermont
Burlington, Vermont 05401, United States
Sentara Cardiovascular
Norfolk, Virginia 23507, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia 23226, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215, United States
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario M4N 3M5, Canada
Toronto General Hospital (University Health Network)
Toronto, Ontario M5G 2C4, Canada
McGill University Health Center - Royal Victoria Hospital
Montreal, Quebec H3A 1A1, Canada
Montreal Heart Institute
Montreal, Canada
Rigshospitalet
Copenhagen, Denmark
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Bad Krozingen, 79106, Germany
Universitätsklinikum Bonn
Bonn, Germany
Deutsches Herzzentrum Muenchen
Munich, Germany
Amphia Hospital Breda
Breda, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
St. Antonius Hospital, R & D Cardiology
Nieuwegein, Netherlands
Erasmus Medical Center - Rotterdam
Rotterdam, Netherlands
Servicio de Cardiologia del Hospital Virgen de la Victoria
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Karolinska Universitetssjukhuset Stockholm
Stockholm, 171 76, Sweden
Bern University Hospital
Bern, Switzerland
Universitatsspital Zurich
Zurich, Switzerland
Leeds General Infirmary
Leeds, United Kingdom
Glenfield Hospital, Leicester, UK
Leicester, LE5 4PW, United Kingdom
St. George's Hospital London
London, SW170QT, United Kingdom

References and documents

Publications

Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122. PubMed 38710669 ↗
Kleiman NS, Van Mieghem NM, Reardon MJ, Gada H, Mumtaz M, Olsen PS, Heiser J, Merhi W, Chetcuti S, Deeb GM, Chawla A, Kiaii B, Teefy P, Chu MWA, Yakubov SJ, Windecker S, Althouse AD, Baron SJ. Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients. JACC Cardiovasc Interv. 2024 Apr 22;17(8):979-988. doi: 10.1016/j.jcin.2024.02.014. PubMed 38658126 ↗
O'Hair D, Yakubov SJ, Grubb KJ, Oh JK, Ito S, Deeb GM, Van Mieghem NM, Adams DH, Bajwa T, Kleiman NS, Chetcuti S, Sondergaard L, Gada H, Mumtaz M, Heiser J, Merhi WM, Petrossian G, Robinson N, Tang GHL, Rovin JD, Little SH, Jain R, Verdoliva S, Hanson T, Li S, Popma JJ, Reardon MJ. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023 Feb 1;8(2):111-119. doi: 10.1001/jamacardio.2022.4627. PubMed 36515976 ↗
Tuttle MK, Kiaii B, Van Mieghem NM, Laham RJ, Deeb GM, Windecker S, Chetcuti S, Yakubov SJ, Chawla A, Hockmuth D, Teefy P, Li S, Reardon MJ. Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-Year Analysis From the SURTAVI Trial. JACC Cardiovasc Interv. 2022 Apr 11;15(7):728-738. doi: 10.1016/j.jcin.2022.01.284. PubMed 35393106 ↗
Lanz J, Reardon MJ, Pilgrim T, Stortecky S, Deeb GM, Chetcuti S, Yakubov SJ, Gleason TG, Huang J, Windecker S. Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement. J Am Heart Assoc. 2021 Oct 5;10(19):e020368. doi: 10.1161/JAHA.120.020368. Epub 2021 Sep 28. PubMed 34581194 ↗
Mumtaz M, Wyler von Ballmoos MC, Deeb GM, Popma JJ, Van Mieghem NM, Kleiman NS, Gleason TG, Chawla A, Hockmuth D, Zorn GL 3rd, Tadros P, Li S, Reardon MJ. The Impact of Transfusions on Mortality After Transcatheter or Surgical Aortic Valve Replacement. Ann Thorac Surg. 2021 Sep;112(3):778-785. doi: 10.1016/j.athoracsur.2020.09.031. Epub 2020 Nov 17. PubMed 33217396 ↗
Attizzani GF, Dallan LAP, Markowitz A, Yakubov SJ, Deeb GM, Reardon MJ, Forrest JK, Mangi AA, Huang J, Popma JJ. Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1816-1824. doi: 10.1016/j.jcin.2020.04.028. PubMed 32763073 ↗
Yakubov SJ, Van Mieghem NM, Reardon MJ, Serruys PW, Gada H, Mumtaz M, Deeb GM, Kodali S, George I, Windecker S, Kleiman N, Chetcuti SJ, Sanchez C, Dauerman HL, Li S, Popma JJ. Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial). Am J Cardiol. 2020 Sep 15;131:82-90. doi: 10.1016/j.amjcard.2020.06.051. Epub 2020 Jun 29. PubMed 32723555 ↗
Van Mieghem NM, Reardon MJ, Yakubov SJ, Heiser J, Merhi W, Windecker S, Makkar RR, Cheng W, Robbins M, Fail P, Feinberg E 2nd, Stoler RC, Hebeler R, Serruys PW, Popma JJ. Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial. EuroIntervention. 2020 Nov 20;16(10):833-841. doi: 10.4244/EIJ-D-20-00303. PubMed 32715995 ↗
Lindman BR, Goel K, Bermejo J, Beckman J, O'Leary J, Barker CM, Kaiser C, Cavalcante JL, Elmariah S, Huang J, Hickey GL, Adams DH, Popma JJ, Reardon MJ. Lower Blood Pressure After Transcatheter or Surgical Aortic Valve Replacement is Associated with Increased Mortality. J Am Heart Assoc. 2019 Nov 5;8(21):e014020. doi: 10.1161/JAHA.119.014020. Epub 2019 Oct 31. PubMed 31665959 ↗
Sondergaard L, Popma JJ, Reardon MJ, Van Mieghem NM, Deeb GM, Kodali S, George I, Williams MR, Yakubov SJ, Kappetein AP, Serruys PW, Grube E, Schiltgen MB, Chang Y, Engstrom T. Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial. Circulation. 2019 Oct 15;140(16):1296-1305. doi: 10.1161/CIRCULATIONAHA.118.039564. Epub 2019 Sep 3. PubMed 31476897 ↗
Reardon MJ, Heijmen RH, Van Mieghem NM, Williams MR, Yakubov SJ, Watson D, Kleiman NS, Conte J, Chawla A, Hockmuth D, Petrossian G, Robinson N, Kappetein AP, Li S, Popma JJ. Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial. JAMA Cardiol. 2019 Aug 1;4(8):810-814. doi: 10.1001/jamacardio.2019.1856. PubMed 31215985 ↗
Head SJ, Reardon MJ, Deeb GM, Van Mieghem NM, Popma JJ, Gleason TG, Williams MR, Radhakrishnan S, Fremes S, Oh JK, Chang Y, Boulware MJ, Kappetein AP. Computed Tomography-Based Indexed Aortic Annulus Size to Predict Prosthesis-Patient Mismatch. Circ Cardiovasc Interv. 2019 Apr;12(4):e007396. doi: 10.1161/CIRCINTERVENTIONS.118.007396. PubMed 30929507 ↗
Durko AP, Reardon MJ, Kleiman NS, Popma JJ, Van Mieghem NM, Gleason TG, Bajwa T, O'Hair D, Brown DL, Ryan WH, Chang Y, De Leon SD, Kappetein AP. Neurological Complications After Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2018 Oct 30;72(18):2109-2119. doi: 10.1016/j.jacc.2018.07.093. PubMed 30360820 ↗
Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17. PubMed 28304219 ↗
Haussig S, Linke A. Patient selection for TAVI 2015 - TAVI in low-risk patients: fact or fiction? EuroIntervention. 2015 Sep;11 Suppl W:W86-91. doi: 10.4244/EIJV11SWA27. PubMed 26384204 ↗
Piazza N, Kalesan B, van Mieghem N, Head S, Wenaweser P, Carrel TP, Bleiziffer S, de Jaegere PP, Gahl B, Anderson RH, Kappetein AP, Lange R, Serruys PW, Windecker S, Juni P. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv. 2013 May;6(5):443-51. doi: 10.1016/j.jcin.2013.01.136. PubMed 23702009 ↗

Study documents

Protocol and statistical analysis plan · May 31, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01586910
Lead sponsor: Medtronic Cardiovascular
Responsible party: Sponsor
First posted: Apr 27, 2012
Start date: Apr 2012
Primary completion: Jul 2018
Completion: Nov 2026 (estimated)
Results posted: Sep 17, 2019
Last update: Jun 24, 2026

Study contacts

Stephan Windecker, MD, PhD

principal investigator · Bern University Hospital

Rüdiger Lange, MD, PhD

principal investigator · Deutsches Herzzentrum München

Thomas Walther, MD, PhD

principal investigator · Kerckhoff Klinik

Michael J. Reardon, MD

principal investigator · The Methodist Hospital Research Institute

David H. Adams, MD

principal investigator · Icahn School of Medicine at Mount Sinai

Nicolas M. Van Mieghem, MD

study chair · Erasmus Medical Center

Patrick W. Serruys, MD, PhD

study chair · National Heart & Lung Institute of Imperial College in London

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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Other studies from this sponsor

Medtronic Cardiovascular

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