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CompletedNCT02738853Updated Mar 21, 2023Results posted

The Medtronic TAVR 2.0 US Clinical Study

An interventional study of Medtronic Transcatheter Aortic Valve 2.0 Replacement System in Aortic Valve Stenosis, sponsored by Medtronic Cardiovascular. Completed at 8 sites in United States. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by Medtronic Cardiovascular (part of Medtronic) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Not applicable
Sex
All
01

Study summary

The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement

Read the detailed description

Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.

02

Conditions studied

  • Aortic Valve Stenosis
03

In context

Aortic Valve Stenosis

1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.

This study's enrollment of 93 is below the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Medtronic Cardiovascular is the lead sponsor of 70 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.

Browse Medtronic Cardiovascular studies →All Medtronic studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Severe aortic stenosis, defined as aortic valve area of \<1.0 cm2 (or aortic valve area index of \<0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
  2. Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities
  3. Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
  4. 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 which cannot be adequately pre medicated:

    • aspirin or heparin (HIT/HITTS) and bivalirudin
    • ticlopidine and clopidogrel
    • nitinol (titanium or nickel)
    • 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. Untreated clinically significant coronary artery disease requiring revascularization
  5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
  6. End stage renal disease requiring chronic dialysis or creatinine clearance \<20 cc/min.
  7. Ongoing sepsis, including active endocarditis
  8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
  9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
  10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  12. Gastrointestinal (GI) bleeding that would preclude anticoagulation
  13. Subject refuses a blood transfusion
  14. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
  15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
  16. 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
  17. Currently participating in an investigational drug or another device study (excluding registries)
  18. Evidence of an acute myocardial infarction ≤30 days before the study procedure
  19. Need for emergency surgery for any reason
  20. Liver failure (Child-Pugh class C)
  21. Subject is pregnant or breast feeding
  22. Pre existing prosthetic heart valve in any position
  23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
  24. Severe mitral regurgitation
  25. Severe tricuspid regurgitation
  26. Moderate or severe mitral stenosis
  27. Hypertrophic obstructive cardiomyopathy
  28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
  29. Congenital bicuspid or unicuspid valve verified by echocardiography
  30. Access vessel diameter \<5.5 mm or \<6.0 mm for patent left internal mammary artery (LIMA)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Medtronic Transcatheter Aortic Valve 2.0 Replacement System

    Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System

    Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement System

Interventions

  • DeviceMedtronic Transcatheter Aortic Valve 2.0 Replacement System

    Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

06

What researchers measure

Primary outcomes

  1. All-cause Mortality Rate

    Time frame: 30 days

  2. Stroke (Disabling) Rate

    Time frame: 30 days

  3. The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram

    Time frame: 30 days

Secondary outcomes

  1. Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:

    1. All-cause mortality \> 2. All stroke (disabling and non-disabling) \> 3. Life-threatening bleeding \> 4. Acute kidney injury: stage 2 or 3 (including renal replacement therapy) \> 5. Coronary artery obstruction requiring intervention \> 6. Major vascular complication \> 7. Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)

    Time frame: 30 days

  2. Percentage of Participants With Life Threatening or Disabling Bleeding

    Percentage of participants with life threatening or disabling bleeding - VARC-II definitions

    Time frame: 30 days

  3. Percentage of Participants With Major Vascular Complication

    Percentage of participants with major vascular complication - VARC-II definition

    Time frame: 30 days

  4. Percentage of Participants With Coronary Artery Obstruction

    Percentage of participants with coronary artery obstruction - VARC-II definitions

    Time frame: 30 days

  5. Percentage of Patient With Acute Kidney Injury- Stage 2 or 3

    Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions

    Time frame: 30 days

  6. Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure

    Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition

    Time frame: 30 days

  7. Device Success Rate (VARC II)

    Time frame: 24 hours to 7 days

  8. Hemodynamic Performance - Aortic Valve Area

    Aortic Valve Area (cm2) by transthoracic echocardiogram

    Time frame: 30 days

  9. Hemodynamic Performance - Mean Gradient

    Mean gradient (mmHg) by transthoracic echocardiogram

    Time frame: 30 days

  10. Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace

    Total prosthetic regurgitation by transthoracic echocardiogram

    Time frame: 30 days

07

Results

Posted Feb 8, 2018

Participant flow

Enrollment
Participant flow — Enrollment
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started93
Completed60
Not completed33
Withdrew: Inclusion/exclusion not met21
Withdrew: Withdrawal by subject3
Withdrew: Subject treated with commercially available device6
Withdrew: Study enrollment closed3
Procedure
Participant flow — Procedure
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started60
Completed59
Not completed1
Withdrew: Death1
1 Month
Participant flow — 1 Month
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started59
Completed57
Not completed2
Withdrew: Death2
6 Month
Participant flow — 6 Month
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started57
Completed51
Not completed6
Withdrew: Death4
Withdrew: Withdrawal by subject2
1 Year
Participant flow — 1 Year
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started51
Completed44
Not completed7
Withdrew: Death6
Withdrew: Withdrawal by subject1
2 Year
Participant flow — 2 Year
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started44
Completed41
Not completed3
Withdrew: Death2
Withdrew: Lost to follow-up1
3 Year
Participant flow — 3 Year
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started41
Completed38
Not completed3
Withdrew: Death2
Withdrew: Withdrawal by subject1
4 Year
Participant flow — 4 Year
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started38
Completed29
Not completed9
Withdrew: Death9
5 Year
Participant flow — 5 Year
MilestoneMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Started29
Completed25
Not completed4
Withdrew: Lost to follow-up4

Outcome measures

PrimaryAll-cause Mortality Rate
Time frame:
30 days
Reported as:
Number · percentage of participants
All-cause Mortality Rate
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
All-cause Mortality Rate1.7 (0.2 to 11.2)
PrimaryStroke (Disabling) Rate
Time frame:
30 days
Reported as:
Number · percentage of participants
Stroke (Disabling) Rate
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Stroke (Disabling) Rate1.7 (0.2 to 11.4)
PrimaryThe Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
Time frame:
30 days
Reported as:
Number · percentage of participants
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram72.4 (59.1 to 83.3)
SecondaryEvent Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:

1. All-cause mortality \> 2. All stroke (disabling and non-disabling) \> 3. Life-threatening bleeding \> 4. Acute kidney injury: stage 2 or 3 (including renal replacement therapy) \> 5. Coronary artery obstruction requiring intervention \> 6. Major vascular complication \> 7. Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)

Time frame:
30 days
Reported as:
Number · percentage of participants
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:15.0 (8.1 to 26.8)
SecondaryPercentage of Participants With Life Threatening or Disabling Bleeding

Percentage of participants with life threatening or disabling bleeding - VARC-II definitions

Time frame:
30 days
Reported as:
Number · percentage of participants
Percentage of Participants With Life Threatening or Disabling Bleeding
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Percentage of Participants With Life Threatening or Disabling Bleeding11.7 (5.7 to 22.9)
SecondaryPercentage of Participants With Major Vascular Complication

Percentage of participants with major vascular complication - VARC-II definition

Time frame:
30 days
Reported as:
Number · percentage of participants
Percentage of Participants With Major Vascular Complication
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Percentage of Participants With Major Vascular Complication10.0 (4.6 to 20.9)
SecondaryPercentage of Participants With Coronary Artery Obstruction

Percentage of participants with coronary artery obstruction - VARC-II definitions

Time frame:
30 days
Reported as:
Number · percentage of participants
Percentage of Participants With Coronary Artery Obstruction
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Percentage of Participants With Coronary Artery Obstruction0.0 (0.0 to 6.1)
SecondaryPercentage of Patient With Acute Kidney Injury- Stage 2 or 3

Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions

Time frame:
30 days
Reported as:
Number · percentage of participants
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Percentage of Patient With Acute Kidney Injury- Stage 2 or 31.7 (0.2 to 11.2)
SecondaryPercentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure

Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition

Time frame:
30 days
Reported as:
Number · percentage of participants
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure0.0 (0.0 to 6.1)
SecondaryDevice Success Rate (VARC II)
Time frame:
24 hours to 7 days
Reported as:
Number · percentage of participants
Device Success Rate (VARC II)
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Device Success Rate (VARC II)80.8 (67.5 to 90.4)
SecondaryHemodynamic Performance - Aortic Valve Area

Aortic Valve Area (cm2) by transthoracic echocardiogram

Time frame:
30 days
Reported as:
Mean · cm2
Hemodynamic Performance - Aortic Valve Area
cm2Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Hemodynamic Performance - Aortic Valve Area2.0 ± 0.5
SecondaryHemodynamic Performance - Mean Gradient

Mean gradient (mmHg) by transthoracic echocardiogram

Time frame:
30 days
Reported as:
Mean · mmHg
Hemodynamic Performance - Mean Gradient
mmHgMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Hemodynamic Performance - Mean Gradient6.4 ± 2.1
SecondaryHemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace

Total prosthetic regurgitation by transthoracic echocardiogram

Time frame:
30 days
Reported as:
Number · percentage of participants
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace
percentage of participantsMedtronic Transcatheter Aortic Valve 2.0 Replacement System
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace72.4

Adverse events

Collected over All events 6 months, All Cause Mortality 60 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAVR 2.026/60 (43.3%)39/60 (65%)38/60 (63.3%)
Most frequent serious events
Showing 10 of 60
Most frequent serious events
EventTAVR 2.0
Atrioventricular Block CompleteCardiac disorders8/60
AnaemiaBlood and lymphatic system disorders7/60
Atrial FibrillationCardiac disorders4/60
Urinary Tract InfectionInfections and infestations4/60
Cardiac Failure CongestiveCardiac disorders3/60
Pericardial EffusionCardiac disorders3/60
PneumoniaInfections and infestations3/60
Cerebrovascular AccidentNervous system disorders3/60
Urinary RetentionRenal and urinary disorders3/60
HypotensionVascular disorders3/60
Most frequent other events
Most frequent other events
EventTAVR 2.0
Bundle Branch Block LeftCardiac disorders21/60
ThrombocytopeniaBlood and lymphatic system disorders10/60
Atrioventricular Block First DegreeCardiac disorders8/60
AnaemiaBlood and lymphatic system disorders6/60
Atrial FibrillationCardiac disorders6/60
Pleural EffusionRespiratory, thoracic and mediastinal disorders6/60
Cardiac Failure CongestiveCardiac disorders5/60
Urinary Tract InfectionInfections and infestations5/60
HypocalcaemiaMetabolism and nutrition disorders5/60
LeukocytosisBlood and lymphatic system disorders4/60

Baseline characteristics

Age, Continuous
Age, Continuous(years)Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Mean83.3 ± 7.2
Sex: Female, Male
Sex: Female, Male(Participants)Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Female39
Male21
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Region of Enrollment
Region of Enrollment(Participants)Medtronic Transcatheter Aortic Valve 2.0 Replacement System
United States60
08

Study locations

8 sites
  • Yale-New Haven Hospital
    New Haven, Connecticut 06520, United States
  • The University of Kansas Hospital
    Kansas City, Kansas 66160, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Morristown Memorial Hospital
    Morristown, New Jersey 07960, United States
  • NYU / Langone Medical Center
    New York, New York 10016, United States
  • New York-Presbyterian Hospital / Columbia University Medical Center
    New York, New York 10032, United States
  • OhioHealth Riverside Methodist Hospital
    Columbus, Ohio 43214, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Wyler von Ballmoos MC, Reardon MJ, Williams MR, Mangi AA, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Oh JK, Qiao H, Forrest JK. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16. doi: 10.1016/j.carrev.2020.11.007. Epub 2020 Nov 10. PubMed 33199247 ↗
  • Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014. PubMed 29348010 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Nov 2016 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2018, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2016
First posted
Apr 14, 2016
Start
Apr 2016
Primary completionActual
Nov 2016
CompletionActual
Dec 15, 2021
Results first posted
Feb 8, 2018
Last update
Mar 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02738853
Lead sponsor
Medtronic Cardiovascular
Responsible party
Sponsor
First posted
Apr 14, 2016
Start date
Apr 2016
Primary completion
Nov 2016
Completion
Dec 15, 2021
Results posted
Feb 8, 2018
Last update
Mar 21, 2023

Study contacts

John Forrest, MD
principal investigator · Yale New Haven Hospital
Mathew Williams, MD
principal investigator · NYU Langone Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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