Principal Investigator: Vikas Sharma
Keywords: TAVR , SAVR Department: Cardiothoracic Division
IRB Number: 00091735 Co Investigator: Frederick Welt
Specialty: Cardiology, Cardiology, Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: General Cardiology, Heart Failure, Cardiac Mechanical Support
Recruitment Status: Active, not recruiting

Contact Information

Carlyn Sander

Simple Summary

Evaluate the safety and effectiveness of the Medtronic TAVR System in patients with severe aortic stenosis at low risk for SAVRThe primary 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 non- inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVRThe exploratory objective is to evaluate the incidence of Leaflet Thickening or Immobility (LTI) detected by Multi- Detector Computed Tomography (MDCT) following TAVR or SAVR (through sub- study)

Inclusion Criteria

Inclusion Criteria
Prospective subjects must meet all of following inclusion criteria to be eligible for implantation:

  1. Severe aortic stenosis, defined as follows:

    1. a)  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 echocardiography or cardiac catheterization

    2. b)  For asymptomatic patients:

      1. 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 by echocardiography or cardiac catheterization, OR

      2. Aortic valve area of 1.0 cm2 (or aortic valve area index of 0.6 cm2/m2) by the continuity equation, AND a mean gradient 40 mmHg, or maximal aortic valve velocity 4.0 m/sec by echocardiography or cardiac catheterization, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia.

  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

If any of the following exclusion criteria are present, the prospective subject is not eligible for implantation:

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

2. A known hypersensitivity or contraindication to any of the following that cannot be adequately premedicated:
    a. aspirin or heparin (HIT/HITTS) and bivalirudin
    b. ticlopidine and clopidogrel
    c. Nitinol (titanium or nickel)
    d. 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

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

Anatomical exclusion criteria:
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 TAV, or <6.0 mm for patent LIMA, or
access vessel mean diameter < 5.5 mm for Evolut 34R TAV or <6.0 mm for patent LIMA, or access vessel
mean diameter < 6 mm for CoreValve 31 mm TAV.


Participant Reimbursement