Status:
ACTIVE_NOT_RECRUITING
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Symptomatic Aortic Stenosis
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjec...
Detailed Description
This is a prospective, multi-center, international, randomized controlled, post-market trial. The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiori...
Eligibility Criteria
Inclusion
- Heart Team agrees that the subject is deemed symptomatic and is a candidate for transcatheter aortic valve replacement (TAVR)
- Subject has a predicted risk of operative mortality \< 15% as determined by the local Heart Team
- Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest
- Subject has a small aortic annulus as determined by Multi-detector computed tomography (MDCT)
- Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+/FX TAV and Edwards SAPIEN 3/3 Ultra TAV
- Subject's anatomy is suitable for TAVR via transfemoral vessel access
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Exclusion
- Estimated life expectancy of fewer than 2 years
- Multivessel coronary artery disease with a Syntax score \>32 and/or unprotected left main coronary artery(Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned).
- Participating in another trial that may influence the outcome of this trial
- Need for an emergent procedure for any reason
- Contraindicated for treatment with the Evolut PRO/PRO+/FX and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
- 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
- Pregnant, nursing, or planning to be pregnant
- Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
- Subject has an active COVID-19 infection or relevant history of COVID-19
- Previous aortic valve replacement
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
1103 Patients enrolled
Trial Details
Trial ID
NCT04722250
Start Date
April 2 2021
End Date
December 1 2027
Last Update
August 19 2025
Active Locations (92)
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1
Scripps Memorial Hospital
La Jolla, California, United States, 92037
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
Sutter Health
San Francisco, California, United States, 94109
4
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States, 91360