SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Running, not enrolling · Not applicable
Conditions studied: Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
In brief
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.
Key facts
- Study ID
- NCT04722250
- Run by
- Medtronic Cardiovascular
- People needed
- 1103
- Starts
- 2021-04-02
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Sutter Health — San Francisco, California, United States
- Los Robles Hospital and Medical Center — Thousand Oaks, California, United States
- University of Colorado — Aurora, Colorado, United States
- Yale New Haven Hospital — New Haven, Connecticut, United States
- WHC Washington MedStar — Washington D.C., District of Columbia, United States
- Morton Plant Hospital — Clearwater, Florida, United States
- HealthPark Medical Center — Fort Myers, Florida, United States
- University of Florida — Gainesville, Florida, United States
- Mount Sinai Medical Center — Miami Beach, Florida, United States
- Emory Structural Heart Clinic and Emory University Midtown — Atlanta, Georgia, United States
- Piedmont Atlanta Hospital — Atlanta, Georgia, United States
- Wellstar Kennestone Hospital — Marietta, Georgia, United States
- NorthShore Health Systems — Evanston, Illinois, United States
- Advocate Christ Medical Center — Oak Lawn, Illinois, United States
- Saint Vincent Heart Center of Indiana — Carmel, Indiana, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- AscensionVia Christi St. Francis Hospital — Wichita, Kansas, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Ascension St. John Hospital — Detroit, Michigan, United States
- Spectrum Health — Grand Rapids, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Scripps Memorial Hospital — La Jolla, California, United States
Full record on ClinicalTrials.gov
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