Medtronic TAVR Low Risk

Evaluating the safety and effectiveness of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) System in patients with severe aortic stenosis at low risk for SAVR (Surgical Aortic Valve Replacement)
Heart & Vascular - Structural Heart Trials, Heart & Vascular
Sameer Gafoor, MD and Eric Lehr, MD
Medtronic, Inc.
Andrea Drouhard
Inclusion Criteria 

1.  Severe aortic stenosis, defined as follows: 

  • For symptomatic patients: Aortic valve area less than or equal to 1.0 cm2 OR mean gradient greater than or equal to 40 mmHg OR maximal aortic valve velocity greater than or equal to 4.0 m/sec by TTE 
  • 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 ≥r60 mmHg by transthoracic echocardiography, 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, 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, AND a left ventricular ejection fraction < 50%.  

2.  Documented heart team agreement of low risk for SAVR 

3. Subject and treating physician agree that the subject will return for all required post-procedure follow-up visits. 

Exclusion Criteria 

1. Any condition considered a contraindication for placement of bioprosthetic valve 

2. A known hypersensitivity or contraindication to any of the following that cannot be adequately premedicated: aspirin or heparin and bilvalrudin, ticlopidine and clopidogrel, Nitinol (titanium or nickel), contrast media. 

3. Blood dyscrasias as defined: leukopenia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoaguable 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 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.

Andrea Drouhard