Active — Not RecruitingNot Applicable

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

United States1,103 participantsStarted 2021-04-02

Plain-language 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 subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 …

What they're measuring

Mortality, Disabling Stroke or Heart Failure Rehospitalization

Timeframe: 12 months

Bioprosthetic Valve Dysfunction (BVD)

Timeframe: 12 months

Trial details

NCT IDNCT04722250

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-10

Results submitted2024-11-04