Active, not recruitingNo phase
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Key facts
- Who runs it
- Medtronic Cardiovascular
- Where
- Ann Arbor, Asheville, Atlanta, Aurora, Austin, Boston, Buffalo, Carmel, Chapel Hill, Charlottesville, Cincinnati, Clearwater, Cleveland, Dallas, Detroit, Evanston, Falls Church, Fort Myers, Gainesville, Grand Rapids, Harrisburg, Houston, Iowa City, Kansas City, La Jolla, Los Angeles, Marietta, Miami Beach, Morgantown, Morristown, Murray, Nashville, New Haven, New York, Norfolk, Oak Lawn, Philadelphia, Pittsburgh, Plano, Rochester, Saint Cloud, San Francisco, St Louis, St. George, Thousand Oaks, Tulsa, Washington D.C., Wichita, Wynnewood, and York, United StatesSee the 61 sitesAlso in 12 other countries, 31 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 1,103 people enrolled
- Started
- 2 Apr 2021
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
- Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Record updated
- 2 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Contraindicated for treatment with the Evolut PRO/PRO+/FX and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
- Previous aortic valve replacement
- 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
- Subject has an active COVID-19 infection or relevant history of COVID-19
- Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
- Estimated life expectancy of fewer than 2 years
- Participating in another trial that may influence the outcome of this trial
- Need for an emergent procedure for any reason
- Pregnant, nursing, or planning to be pregnant
Where in United States
Also in 12 other countries, 31 sites
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Mission HospitalAsheville, United StatesNo longer taking part
- Emory Structural Heart Clinic and Emory University MidtownAtlanta, United StatesNo longer taking part
- Piedmont Atlanta HospitalAtlanta, United StatesNo longer taking part
- University of ColoradoAurora, United StatesNo longer taking part
- Seton Heart InstituteAustin, United StatesNo longer taking part
- Tufts Medical CenterBoston, United StatesNo longer taking part
- Buffalo General Medical CenterBuffalo, United StatesNo longer taking part
- Saint Vincent Heart Center of IndianaCarmel, United StatesNo longer taking part
- UNC Memorial HospitalChapel Hill, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- TriHealth Bethesda North HospitalCincinnati, United StatesNo longer taking part
- Morton Plant HospitalClearwater, United StatesNo longer taking part
- Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- Baylor Jack and Jane Hamilton Heart and Vascular HospitalDallas, United StatesNo longer taking part
- Texas Health Presbyterian Hospital DallasDallas, United StatesNo longer taking part
- Ascension St. John HospitalDetroit, United StatesNo longer taking part
- NorthShore Health SystemsEvanston, United StatesNo longer taking part
- Inova Fairfax HospitalFalls Church, United StatesNo longer taking part
- HealthPark Medical CenterFort Myers, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- Spectrum HealthGrand Rapids, United StatesNo longer taking part
- UPMC Pinnacle HarrisburgHarrisburg, United StatesNo longer taking part
- Baylor Saint Luke's HospitalHouston, United StatesNo longer taking part
- Houston Methodist HospitalHouston, United StatesNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, United StatesNo longer taking part
- University of Texas Health Sciences Center at Houston - Center for Advanced Heart FailureHouston, United StatesNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Scripps Memorial HospitalLa Jolla, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
- Wellstar Kennestone HospitalMarietta, United StatesNo longer taking part
- Mount Sinai Medical CenterMiami Beach, United StatesNo longer taking part
- J.W. Ruby Memorial Hospital/West Virginia UniversityMorgantown, United StatesNo longer taking part
- Morristown Medical CenterMorristown, United StatesNo longer taking part
- Intermountain Medical CenterMurray, United StatesNo longer taking part
- St. Thomas West HospitalNashville, United StatesNo longer taking part
- TriStar Centennial Medical centerNashville, United StatesNo longer taking part
- Yale New Haven HospitalNew Haven, United StatesNo longer taking part
- NYU Langone Medical CenterNew York, United StatesNo longer taking part
- The Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
- Weill Cornell Medical CenterNew York, United StatesNo longer taking part
- Sentara Norfolk General HospitalNorfolk, United StatesNo longer taking part
- Advocate Christ Medical CenterOak Lawn, United StatesNo longer taking part
- Hospital of the University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Penn Presbyterian Medical CenterPhiladelphia, United StatesNo longer taking part
- Allegheny General HospitalPittsburgh, United StatesNo longer taking part
- UPMC PresbyterianPittsburgh, United StatesNo longer taking part
- The Heart Hospital Baylor PlanoPlano, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- St. Cloud HospitalSaint Cloud, United StatesNo longer taking part
- Sutter HealthSan Francisco, United StatesNo longer taking part
- Missouri Baptist Medical CenterSt Louis, United StatesNo longer taking part
- Saint George Regional HospitalSt. George, United StatesNo longer taking part
- Los Robles Hospital and Medical CenterThousand Oaks, United StatesNo longer taking part
- Hillcrest Medical CenterTulsa, United StatesNo longer taking part
- WHC Washington MedStarWashington D.C., United StatesNo longer taking part
- AscensionVia Christi St. Francis HospitalWichita, United StatesNo longer taking part
- Lankenau Medical CenterWynnewood, United StatesNo longer taking part
- York HospitalYork, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Medtronic Self-Expanding TAVTreatment being tested
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Treatment: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
- Edwards Balloon-Expandable THVTreatment being tested
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Treatment: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 2 June 2026