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Active, not recruitingNCT02701283Updated May 7, 2026Results posted

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

An interventional study of Medtronic Transcatheter Aortic Valve Replacement Systems and Surgical Aortic Valve Replacement (SAVR) in Aortic Valve Stenosis, sponsored by Medtronic Cardiovascular. Active, not recruiting at 87 sites in 7 countries. Per ClinicalTrials.gov, last updated 2026-05-07.

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

Phase
Not applicable
Study type
Interventional
Enrollment
2,223
Allocation
Randomized
Sex
All
01

Study summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Read the detailed description

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.

02

Conditions studied

  • Aortic Valve Stenosis

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03

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 2,223 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.

04

Who can participate

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

Inclusion criteria

  1. Severe aortic stenosis, defined as follows:

    1. For symptomatic patients:

      Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

    2. For asymptomatic patients:

      • Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%.
  2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR \<3% at 30 days per multidisciplinary local heart team assessment.
  3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion criteria

Exclusion Criteria:

  1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).

  2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

    1. aspirin or heparin (HIT/HITTS) and bivalirudin
    2. ticlopidine and clopidogrel
    3. Nitinol (titanium or nickel)
    4. contrast media
  3. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  4. Ongoing sepsis, including active endocarditis.
  5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
  6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
  7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
  8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  11. Subject refuses a blood transfusion.
  12. 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).
  13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
  14. 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.
  15. Currently participating in an investigational drug or another device trial (excluding registries).
  16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
  17. Need for emergency surgery for any reason.
  18. Subject is pregnant or breast feeding.
  19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
  20. Pre-existing prosthetic heart valve in any position.
  21. Severe mitral regurgitation amenable to surgical replacement or repair.
  22. Severe tricuspid regurgitation amenable to surgical replacement or repair.
  23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
  24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
  25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
  26. Prohibitive left ventricular outflow tract calcification.
  27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
  28. Aortic annulus diameter of \<18 or >30 mm.

  29. Significant aortopathy requiring ascending aortic replacement.

    For transfemoral or transaxillary (subclavian) access:

  30. Access vessel mean diameter \<5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter \<5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<6.0 mm for the Evolut 34R or Evolut PRO TAV.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,223 participants (actual)

Study arms

  • Experimental
    Medtronic Transcatheter Aortic Valve Replacement Systems

    Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

    Device: Medtronic Transcatheter Aortic Valve Replacement Systems

  • Active comparator
    Surgical Aortic Valve Replacement (SAVR)

    Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)

    Device: Surgical Aortic Valve Replacement (SAVR)

Interventions

  • DeviceMedtronic Transcatheter Aortic Valve Replacement Systems

    Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

  • DeviceSurgical Aortic Valve Replacement (SAVR)

    Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

06

What researchers measure

Primary outcomes

  1. Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study

    Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).

    Time frame: Randomized Controlled Trial - 24 months Continued Access Study - 12 months

Secondary outcomes

  1. RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days

    Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication

    Time frame: 30 days

  2. New Pacemaker Implantation at 30 Days

    The rate of new permanent pacemaker implant at 30 days

    Time frame: 30 days

  3. Prosthetic Valve Endocarditis at 1 Year

    The rate of prosthetic valve endocarditis at 1 year

    Time frame: 1 year

  4. Prosthetic Valve Thrombosis at 1 Year

    The rate of prosthetic valve thrombosis at 1 year

    Time frame: 1 year

  5. All Stroke (Disabling and Non-disabling) at 1 Year

    The rate of all stroke (disabling and non-disabling) at 1 year

    Time frame: 1 year

  6. Life-threatening Bleeding at 1 Year

    The rate of life-threatening bleeding at 1 year

    Time frame: 1 year

  7. Valve-related Dysfunction Requiring Repeat Procedure at 1 Year

    The rate of valve-related dysfunction requiring repeat procedure at 1 year

    Time frame: 1 year

  8. Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial

    Stenosis (moderate or severe) Any of the following: 1. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA \<0.8 cm2 2. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA ≥0.8 cm2, and DVI \<0.25 3. Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA \<0.8 cm2, and DVI \<0.25 Regurgitation (moderate or severe) Any of the following: 1. Moderate or Severe Total Regurgitation 2. Moderate or Severe Paravalvular Regurgitation 3. Moderate or Severe Transvalvular Regurgitation

    Time frame: 1 year

  9. Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year

    Quality of life summary scores and change from baseline using the following measures: 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.

    Time frame: Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year

  10. Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial

    The rate of repeat hospitalization for aortic valve disease at 1 year

    Time frame: 1 year

Other outcomes

  1. Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial

    Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation

    Time frame: 1 year

  2. Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year

    Reporting of prosthetic valve hemodynamic performance by EOA

    Time frame: 1 year

  3. Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial

    Quality of life summary scores and change from baseline using the following measures: 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: 1 year

  4. New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial

    Reporting of NYHA classification at 1 year NYHA Classification criteria: 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: 1 year

  5. Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year

    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

    Time frame: 1 year

  6. Efficacy: Device Success Rate

    Assessment of procedural effectiveness by meeting all of the following device success criteria: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

    Time frame: Hospital discharge or 7 days post-procedure (whichever occurs first)

07

Results

Posted Sep 9, 2021

Participant flow

Participant flow — Overall Study
MilestoneRandomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Started737741745
As treated (attempted implant)730684745
Implanted727686745
Completed668579724
Not completed6916221
Withdrew: Death252919
Withdrew: Lost to follow-up381
Withdrew: Withdrawal by subject12411
Withdrew: Missed 2-year visit22270
Withdrew: Exited prior to procedure (3 subjects crossed over from savr to tavr)7570

Outcome measures

PrimarySafety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study

Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).

Time frame:
Randomized Controlled Trial - 24 months Continued Access Study - 12 months
Reported as:
Number · Percent of participants (K-M rate)
Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study4.36.35.7
Statistical analysis
  • Randomized Controlled Trial - Medtronic TAVR Systems vs Randomized Controlled Trial - SAVR · Bayesian · Posterior median of the difference: 0.99995% Bayesian credible interval for the difference (TAVR-SAVR) was (-4.4%, 0.4%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.
SecondaryRCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days

Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication

Time frame:
30 days
Reported as:
Number · Percent of participants (K-M rate)
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Composite event5.310.86.6
Death0.41.20.7
Disabling stroke0.41.6NA
Life-threatening or disabling bleed2.57.53.4
Major vascular complication3.73.10.4
AKI (II or III)0.82.8NA
All StrokeNANA2.7
SecondaryNew Pacemaker Implantation at 30 Days

The rate of new permanent pacemaker implant at 30 days

Time frame:
30 days
Reported as:
Number · Percent of participants (K-M rate)
New Pacemaker Implantation at 30 Days
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
New Pacemaker Implantation at 30 Days17.76.315.0
SecondaryProsthetic Valve Endocarditis at 1 Year

The rate of prosthetic valve endocarditis at 1 year

Time frame:
1 year
Reported as:
Number · Percent of participants (K-M rate)
Prosthetic Valve Endocarditis at 1 Year
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Prosthetic Valve Endocarditis at 1 Year0.10.50.4
SecondaryProsthetic Valve Thrombosis at 1 Year

The rate of prosthetic valve thrombosis at 1 year

Time frame:
1 year
Reported as:
Number · Percent of participants (K-M rate)
Prosthetic Valve Thrombosis at 1 Year
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Prosthetic Valve Thrombosis at 1 Year0.30.20.0
SecondaryAll Stroke (Disabling and Non-disabling) at 1 Year

The rate of all stroke (disabling and non-disabling) at 1 year

Time frame:
1 year
Reported as:
Number · Percent of participants (K-M rate)
All Stroke (Disabling and Non-disabling) at 1 Year
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
All Stroke (Disabling and Non-disabling) at 1 Year4.34.33.6
SecondaryLife-threatening Bleeding at 1 Year

The rate of life-threatening bleeding at 1 year

Time frame:
1 year
Reported as:
Number · Percent of participants (K-M rate)
Life-threatening Bleeding at 1 Year
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Life-threatening Bleeding at 1 Year3.68.73.8
SecondaryValve-related Dysfunction Requiring Repeat Procedure at 1 Year

The rate of valve-related dysfunction requiring repeat procedure at 1 year

Time frame:
1 year
Reported as:
Number · Percent of participants (K-M rate)
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year
Percent of participants (K-M rate)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year0.60.40.8
SecondaryValve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial

Stenosis (moderate or severe) Any of the following: 1. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA \<0.8 cm2 2. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA ≥0.8 cm2, and DVI \<0.25 3. Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA \<0.8 cm2, and DVI \<0.25 Regurgitation (moderate or severe) Any of the following: 1. Moderate or Severe Total Regurgitation 2. Moderate or Severe Paravalvular Regurgitation 3. Moderate or Severe Transvalvular Regurgitation

Time frame:
1 year
Reported as:
Number · Percent of participants
Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial
Percent of participantsMedtronic TAVR SystemsSAVR
Moderate or severe stenosis0.20.4
Moderate or severe regurgitation4.31.3
SecondaryRandomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year

Quality of life summary scores and change from baseline using the following measures: 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.

Time frame:
Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year
Reported as:
Mean · Score on a scale
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year
Score on a scaleRandomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
30 day KCCQ - Overall88.6 ± 14.278.7 ± 18.8NA ± NA
30 day change from baseline - Overall20.0 ± 21.19.2 ± 22.3NA ± NA
30 day KCCQ - Clinical89.7 ± 13.482.6 ± 16.9NA ± NA
30 day change from baseline - Clinical15.4 ± 19.67.5 ± 20.5NA ± NA
1 year KCCQ - Overall90.6 ± 12.790.5 ± 12.491.1 ± 13.8
1 year change from baseline - Overall21.6 ± 20.620.7 ± 20.324.7 ± 22.8
1 year KCCQ - Clinical89.9 ± 13.490.2 ± 12.8NA ± NA
1 year change from baseline - Clinical15.3 ± 18.914.8 ± 18.9NA ± NA
SecondaryRepeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial

The rate of repeat hospitalization for aortic valve disease at 1 year

Time frame:
1 year
Reported as:
Number · Percent of participants (K-M rate)
Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial
Percent of participants (K-M rate)Medtronic TAVR SystemsSAVR
Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial3.55.8
Other pre-specifiedHemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial

Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation

Time frame:
1 year
Reported as:
Number · Percent of participants
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial
Percent of participantsMedtronic TAVR SystemsSAVR
None39.472.2
Trace23.519.3
Mild/Mild to Moderate32.97.2
Moderate/Moderate to Severe4.11.3
Severe0.10.0
Other pre-specifiedHemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year

Reporting of prosthetic valve hemodynamic performance by EOA

Time frame:
1 year
Reported as:
Mean · cm2
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year
cm2Medtronic TAVR SystemsSAVR
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year2.23 ± 0.631.96 ± 0.57
Other pre-specifiedHealth-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial

Quality of life summary scores and change from baseline using the following measures: 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:
1 year
Reported as:
Mean · Score on a scale
Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial
Score on a scaleMedtronic TAVR SystemsSAVR
EQ-5D Index Score at 1 year0.81 ± 0.210.81 ± 0.19
1 year change from baseline EQ-5D Index Score0.09 ± 0.240.08 ± 0.24
Other pre-specifiedNew York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial

Reporting of NYHA classification at 1 year NYHA Classification criteria: 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:
1 year
Reported as:
Number · Percent of participants
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial
Percent of participantsMedtronic TAVR SystemsSAVR
NYHA Class I80.679.5
NYHA Class II15.815.7
NYHA Class III1.11.4
NYHA Class IV0.40.3
Died prior to visit2.13.0
Other pre-specifiedHemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year

Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

Time frame:
1 year
Reported as:
Mean · mmHG
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year
mmHGMedtronic TAVR SystemsSAVR
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year8.74 ± 3.5811.27 ± 4.81
Other pre-specifiedEfficacy: Device Success Rate

Assessment of procedural effectiveness by meeting all of the following device success criteria: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

Time frame:
Hospital discharge or 7 days post-procedure (whichever occurs first)
Reported as:
Number · Percent of participants
Efficacy: Device Success Rate
Percent of participantsRandomized Controlled Trial - Medtronic TAVR SystemsContinued Access Study - Medtronic TAVR Systems
Efficacy: Device Success Rate85.3 (82.1 to 88.1)98.1 (96.9 to 99)

Adverse events

Collected over Randomized Controlled Trial - 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. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Randomized Controlled Trial - Medtronic TAVR Systems25/730 (3.4%)459/730 (62.9%)474/730 (64.9%)
Randomized Controlled Trial - SAVR29/684 (4.2%)495/684 (72.4%)571/684 (83.5%)
Continued Access Study - Medtronic TAVR Systems19/745 (2.6%)429/745 (57.6%)0/745 (0%)
Most frequent serious events
Showing 10 of 616
Most frequent serious events
EventRandomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Atrial FibrillationCardiac disorders38/730135/68412/745
Cardiac Pacemaker InsertionSurgical and medical procedures1/7300/684110/745
HospitalisationSurgical and medical procedures0/7300/684102/745
Atrioventricular Block CompleteCardiac disorders89/73036/6840/745
AnaemiaBlood and lymphatic system disorders22/73060/6840/745
Pleural EffusionRespiratory, thoracic and mediastinal disorders7/73049/6840/745
HypotensionVascular disorders39/73038/6840/745
HypertensionVascular disorders13/73033/6840/745
Fluid OverloadMetabolism and nutrition disorders5/73029/6840/745
PneumoniaInfections and infestations11/73028/6840/745
Most frequent other events
Showing 10 of 20
Most frequent other events
EventRandomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR Systems
Bundle Branch Block LeftCardiac disorders246/730141/684—
ThrombocytopeniaBlood and lymphatic system disorders56/730196/684—
LeukocytosisBlood and lymphatic system disorders57/730163/684—
Atrial FibrillationCardiac disorders55/730151/684—
AnaemiaBlood and lymphatic system disorders50/730145/684—
Atrioventricular Block First DegreeCardiac disorders115/730119/684—
Pleural EffusionRespiratory, thoracic and mediastinal disorders0/730109/684—
HypertensionVascular disorders76/73062/684—
AtelectasisRespiratory, thoracic and mediastinal disorders0/73069/684—
HyperglycaemiaMetabolism and nutrition disorders0/73065/684—

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
Mean74.1 ± 5.873.7 ± 5.974.9 ± 5.973.9 ± 5.9
Sex: Female, Male
Sex: Female, Male(Participants)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
Female266233246745
Male4644514991414
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
Hispanic or LatinoNANA25NA
Not Hispanic or LatinoNANA705NA
Unknown or Not ReportedNANA15NA
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
American Indian or Alaska NativeNANA3NA
AsianNANA4NA
Native Hawaiian or Other Pacific IslanderNANA1NA
Black or African AmericanNANA15NA
WhiteNANA707NA
More than one raceNANA0NA
Unknown or Not ReportedNANA15NA
Subject characteristic - subject age
Subject characteristic - subject age(Years)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
Mean74.1 ± 5.873.7 ± 5.974.9 ± 5.973.9 ± 5.9
Subject characteristic - body surface area
Subject characteristic - body surface area(m^2)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
Mean2.0 ± 0.22.0 ± 0.22.0 ± 0.22.0 ± 0.2
Subject characteristic - SYNTAX Score I, Randomized Controlled Trial
Subject characteristic - SYNTAX Score I, Randomized Controlled Trial(Scores on a scale)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
Mean1.9 ± 3.72.1 ± 3.9NA ± NA2.0 ± 3.8
Society of Thoracic Surgeons (STS) score
Society of Thoracic Surgeons (STS) score(Scores on a scale)Randomized Controlled Trial - Medtronic TAVR SystemsRandomized Controlled Trial - SAVRContinued Access Study - Medtronic TAVR SystemsTotal
Mean2.0 ± 0.71.9 ± 0.71.6 ± 0.61.9 ± 0.7

8 further baseline measures are reported on the registry.

08

Study locations

87 sites
  • Abrazo Arizona Heart Hospital
    Phoenix, Arizona 85016, United States
  • Scripps Memorial Hospital La Jolla
    La Jolla, California 92037, United States
  • University of Southern California University Hospital
    Los Angeles, California 90033, United States
  • El Camino Hospital
    Mountain View, California 64040, United States
  • Mercy General Hospital
    Sacramento, California 95816, United States
  • Los Robles Hospital & Medical Center
    Thousand Oaks, California 91360, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Yale New Haven Hospital
    New Haven, Connecticut 06520, United States
  • Morton Plant Hospital
    Clearwater, Florida 33756, United States
  • Delray Medical Center
    Delray Beach, Florida 33484, United States
  • HealthPark Medical Center
    Fort Myers, Florida 33908, United States
  • University of Miami Hospital
    Miami, Florida 33136, United States
  • Tallahassee Research Institute, Inc.
    Tallahassee, Florida 32308, United States
  • Piedmont Atlanta Hospital
    Atlanta, Georgia 30309, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Saint Vincent Heart Center of Indiana
    Indianapolis, Indiana 46290, United States
  • Mercy Medical Center
    Des Moines, Iowa 50314, United States
  • The University of Kansas Hospital
    Kansas City, Kansas 66160, United States
  • Jewish Hospital
    Louisville, Kentucky 40202, United States
  • Terrebonne General Medical Center
    Houma, Louisiana 70360, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • MedStar Union Memorial Hospital
    Baltimore, Maryland 21218, United States
  • The Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
  • University of Michigan Health System
    Ann Arbor, Michigan 48109, United States
  • Saint John Hospital and Medical Center
    Detroit, Michigan 48236, United States
  • Spectrum Health Hospitals
    Grand Rapids, Michigan 49503, United States
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Mercy Hospital
    Springfield, Missouri 65806, United States
  • Saint Francis Hospital
    East Hills, New York 11548, United States
  • Saint Joseph's Hospital Health Center
    Liverpool, New York 13088, United States
  • Northwell Health
    Manhasset, New York 11030, United States
  • The Mount Sinai Hospital
    New York, New York 10029, United States
  • Strong Memorial Hospital
    Rochester, New York 14642, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Wake Forest Baptist Medical Center
    Winston-Salem, North Carolina 27157, United States
  • Sanford Medical Center
    Fargo, North Dakota 58102, 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
  • OhioHealth Riverside Methodist Hospital
    Columbus, Ohio 43214, United States
  • Integris Baptist Medical Center
    Oklahoma City, Oklahoma 73112, United States
  • Oregon Health Science University
    Portland, Oregon 97239, United States
  • Lehigh Valley Hospital
    Allentown, Pennsylvania 18103, United States
  • Geinsinger Medical Center
    Danville, Pennsylvania 17043, United States
  • Pinnacle Health
    Harrisburg, Pennsylvania 17043, United States
  • University of Pittsburgh Medical Center UPMC Presbyterian
    Pittsburgh, Pennsylvania 15232, United States
  • Paramount Heart
    Villanova, Pennsylvania 19085, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
    Dallas, Texas 75204, United States
  • Baylor Saint Luke's Medical Center
    Houston, Texas 77030, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
  • Methodist Hospital San Antonio
    San Antonio, Texas 78229, United States
  • University Hospital Salt Lake City Utah
    Salt Lake City, Utah 84132, United States
  • The University of Vermont Medical Center
    Burlington, Vermont 05401, United States
  • Saint Mary's Hospital
    Richmond, Virginia 23226, United States
  • Swedish Medical Center
    Seattle, Washington 98122, United States
  • Aurora Saint Luke's Medical Center
    Milwaukee, Wisconsin 53215, United States
  • Saint Vincent's Hospital Sydney
    Darlinghurst, New South Wales 2010, Australia
  • Royal North Shore Hospital
    St Leonards, New South Wales 2065, Australia
  • Monash Health
    Clayton, Victoria 3168, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Fiona Stanley Hospital (FSH)
    Murdoch, Western Australia 6150, Australia
  • London Health Sciences Centre
    London, Ontario N6A 5A5, Canada
  • Toronto General Health Hospital
    Toronto, Ontario MSG2C4, Canada
  • Glen Royal Victoria (McGill)
    Montreal, Quebec H4A 3J1, Canada
  • IUCPQ
    Québec, Quebec G1V 4G5, Canada
  • Montreal Heart
    Montreal, H1T 1C8, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, Canada
  • Centre Hospitalier Régional Universitaire de Lille
    Lille, 59000, France
  • L'Hôpital Privé Jacques Cartier Massy
    Massy, 91300, France
  • Clinique Pasteur
    Toulouse, 31300, France
  • Kokura Memorial Hospital
    Kitakyushu, Fokuoka, Japan
  • Sapporo Higashi Tokushukai Hospital
    Sapporo, Hokkaido, Japan
  • Teikyo University Hospital
    Tokyo, Itabashi-Ku, Japan
  • Shonan Kamakura General Hospital
    Kamakura, Kanagawa, Japan
  • Sendai Kousei Hospital
    Sendai, Miyagi, Japan
  • National Cerebral and Cardiovasclular Center
    Suita, Osaka, Japan
  • The University of Osaka Hospital
    Suita, Osaka, Japan
  • Sakakibara Heart Institute
    Fuchū, Tokyo, Japan
  • Catharina Ziekenhuis
    Eindhoven, 5623, Netherlands
  • St. Antonius Hospital Nieuwegein
    Nieuwegein, 3435, Netherlands
  • Erasmus Medisch Centrum
    Rotterdam, 3015, Netherlands
  • Waikato Hospital
    Hamilton, New Zealand
09

References and documents

Publications

  • Forrest JK, Yakubov SJ, Deeb GM, Reardon MJ; Evolut Low Risk Trial Investigators. Six-Year Outcomes After Transcatheter vs Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2026 Jun 16;87(23):3210-3221. doi: 10.1016/j.jacc.2026.02.5063. Epub 2026 Feb 16. PubMed 41697183 ↗
  • Erdem S, Goel SS, Reardon MJ. Five-year Outcomes of Transcatheter Aortic Valve Replacement Versus Surgery in Low-risk Aortic Stenosis: Insights from the Evolut Low Risk Trial. Heart Int. 2025 Nov 24;19(2):3-4. doi: 10.17925/HI.2025.19.2.5. eCollection 2025. PubMed 41377641 ↗
  • Forrest JK, Yakubov SJ, Deeb GM, Gada H, Mumtaz MA, Ramlawi B, Bajwa T, Crouch J, Merhi W, Wai Sang SL, Kleiman NS, Petrossian G, Robinson NB, Sorajja P, Iskander A, Berthoumieu P, Tchetche D, Feindel C, Horlick EM, Saito S, Oh JK, Jung Y, Reardon MJ; Low Risk Trial Investigators. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2025 Apr 22;85(15):1523-1532. doi: 10.1016/j.jacc.2025.03.004. Epub 2025 Mar 30. PubMed 40158212 ↗
  • Butala NM, Lalani C, Tale A, Song Y, Kolte D, Baron S, Strom J, Cohen DJ, Yeh RW. Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial. Circ Cardiovasc Interv. 2025 Jan;18(1):e014592. doi: 10.1161/CIRCINTERVENTIONS.124.014592. Epub 2025 Jan 21. PubMed 39836743 ↗
  • Modine T, Tchetche D, Van Mieghem NM, Deeb GM, Chetcuti SJ, Yakubov SJ, Sorajja P, Gada H, Mumtaz M, Ramlawi B, Bajwa T, Crouch J, Teirstein PS, Kleiman NS, Iskander A, Bagur R, Chu MWA, Berthoumieu P, Sudre A, Adrichem R, Ito S, Huang J, Popma JJ, Forrest JK, Reardon MJ. Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients. Circ Cardiovasc Interv. 2024 Nov;17(11):e014018. doi: 10.1161/CIRCINTERVENTIONS.124.014018. Epub 2024 Oct 18. PubMed 39421943 ↗
  • 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 ↗
  • Tang GHL, Spencer J, Rogers T, Grubb KJ, Gleason P, Gada H, Mahoney P, Dauerman HL, Forrest JK, Reardon MJ, Blanke P, Leipsic JA, Abdel-Wahab M, Attizzani GF, Puri R, Caskey M, Chung CJ, Chen YH, Dudek D, Allen KB, Chhatriwalla AK, Htun WW, Blackman DJ, Tarantini G, Zhingre Sanchez J, Schwartz G, Popma JJ, Sathananthan J. Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study. Circ Cardiovasc Interv. 2023 Nov;16(11):e013238. doi: 10.1161/CIRCINTERVENTIONS.123.013238. Epub 2023 Nov 21. PubMed 37988439 ↗
  • Grubb KJ, Shekiladze N, Spencer J, Perdoncin E, Tang GHL, Xie J, Lisko J, Sanchez JZ, Lucas LM, Sathananthan J, Rogers T, Deeb GM, Fukuhara S, Blanke P, Leipsic JA, Forrest JK, Reardon MJ, Gleason P. Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy. EuroIntervention. 2023 Jul 17;19(4):e330-e339. doi: 10.4244/EIJ-D-22-01125. PubMed 37067193 ↗
  • Forrest JK, Deeb GM, Yakubov SJ, Gada H, Mumtaz MA, Ramlawi B, Bajwa T, Teirstein PS, DeFrain M, Muppala M, Rutkin BJ, Chawla A, Jenson B, Chetcuti SJ, Stoler RC, Poulin MF, Khabbaz K, Levack M, Goel K, Tchetche D, Lam KY, Tonino PAL, Ito S, Oh JK, Huang J, Popma JJ, Kleiman N, Reardon MJ; Low Risk Trial Investigators. 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2023 May 2;81(17):1663-1674. doi: 10.1016/j.jacc.2023.02.017. Epub 2023 Mar 5. PubMed 36882136 ↗
  • Ramlawi B, Deeb GM, Yakubov SJ, Markowitz AH, Hughes GC, Kiaii RB, Huang J, Kleiman NS, Reardon MJ. Mechanisms of Death in Low-Risk Patients After Transcatheter or Surgical Aortic Valve Replacement. Cardiovasc Revasc Med. 2022 Sep;42:1-5. doi: 10.1016/j.carrev.2022.03.027. Epub 2022 Mar 29. PubMed 35398007 ↗
  • Forrest JK, Deeb GM, Yakubov SJ, Rovin JD, Mumtaz M, Gada H, O'Hair D, Bajwa T, Sorajja P, Heiser JC, Merhi W, Mangi A, Spriggs DJ, Kleiman NS, Chetcuti SJ, Teirstein PS, Zorn GL 3rd, Tadros P, Tchetche D, Resar JR, Walton A, Gleason TG, Ramlawi B, Iskander A, Caputo R, Oh JK, Huang J, Reardon MJ. 2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. J Am Coll Cardiol. 2022 Mar 8;79(9):882-896. doi: 10.1016/j.jacc.2021.11.062. PubMed 35241222 ↗
  • 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 ↗
  • Blanke P, Leipsic JA, Popma JJ, Yakubov SJ, Deeb GM, Gada H, Mumtaz M, Ramlawi B, Kleiman NS, Sorajja P, Askew J, Meduri CU, Kauten J, Melnitchouk S, Inglessis I, Huang J, Boulware M, Reardon MJ; Evolut Low Risk LTI Substudy Investigators. Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study. J Am Coll Cardiol. 2020 May 19;75(19):2430-2442. doi: 10.1016/j.jacc.2020.03.022. Epub 2020 Mar 28. PubMed 32234463 ↗
  • Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16. PubMed 30883053 ↗
  • Leipsic J, Bax JJ, Webb JG, Martin R, Blanke P. Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions. JACC Cardiovasc Imaging. 2017 Mar;10(3):286-295. doi: 10.1016/j.jcmg.2016.09.031. PubMed 28279376 ↗

Study documents

  • Study protocol · Jul 16, 2018
  • Statistical analysis plan · Jul 17, 2018

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02701283
Lead sponsor
Medtronic Cardiovascular
Responsible party
Sponsor
First posted
Mar 8, 2016
Start date
Mar 2016
Primary completion
Apr 2021
Completion
Jun 2029 (estimated)
Results posted
Sep 9, 2021
Last update
May 7, 2026

Study contacts

Michael Reardon, MD
principal investigator · The Methodist Hospital Research Institute
John K. Forrest, MD
principal investigator · Yale New Haven Hospital

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.

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