- Trial ID:
- Paul Teirstein
- 1. Severe aortic stenosis, defined as follows:
- 1. For symptomatic patients:
- 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.
- 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.
- 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.
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
For transfemoral or transaxillary (subclavian) access:
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
How else can Scripps help me?
We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.
How can I find trials that are accepting new participants?
For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.