SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

NCT04722250 · tracked via the Priya Life Science UK tracker

Sponsor

Medtronic Cardiovascular

Phase

Not applicable

Started

2021-04-02

Last updated

2026-06-02

Condition(s) studied

Symptomatic Aortic StenosisAortic Valve StenosisAortic Valve Replacement

Investigational drug(s) / intervention(s)

Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV SystemsEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems

Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)

Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 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

Primary outcome measure(s)

Mortality, Disabling Stroke or Heart Failure Rehospitalization — 12 months
Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
Bioprosthetic Valve Dysfunction (BVD) — 12 months
Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))

Trial sites (92)

Facility	City	Region
Scripps Memorial Hospital	La Jolla	California
Cedars Sinai Medical Center	Los Angeles	California
Sutter Health	San Francisco	California
Los Robles Hospital and Medical Center	Thousand Oaks	California
University of Colorado	Aurora	Colorado
Yale New Haven Hospital	New Haven	Connecticut
WHC Washington MedStar	Washington D.C.	District of Columbia
Morton Plant Hospital	Clearwater	Florida
HealthPark Medical Center	Fort Myers	Florida
University of Florida	Gainesville	Florida
Mount Sinai Medical Center	Miami Beach	Florida
Emory Structural Heart Clinic and Emory University Midtown	Atlanta	Georgia
Piedmont Atlanta Hospital	Atlanta	Georgia
Wellstar Kennestone Hospital	Marietta	Georgia
NorthShore Health Systems	Evanston	Illinois
Advocate Christ Medical Center	Oak Lawn	Illinois
Saint Vincent Heart Center of Indiana	Carmel	Indiana
University of Iowa Hospitals and Clinics	Iowa City	Iowa
University of Kansas Medical Center	Kansas City	Kansas
AscensionVia Christi St. Francis Hospital	Wichita	Kansas
Tufts Medical Center	Boston	Massachusetts
University of Michigan	Ann Arbor	Michigan
Ascension St. John Hospital	Detroit	Michigan
Spectrum Health	Grand Rapids	Michigan
Mayo Clinic	Rochester	Minnesota
St. Cloud Hospital	Saint Cloud	Minnesota
Missouri Baptist Medical Center	St Louis	Missouri
Morristown Medical Center	Morristown	New Jersey
Buffalo General Medical Center	Buffalo	New York
NYU Langone Medical Center	New York	New York
The Icahn School of Medicine at Mount Sinai	New York	New York
Weill Cornell Medical Center	New York	New York
Mission Hospital	Asheville	North Carolina
UNC Memorial Hospital	Chapel Hill	North Carolina
TriHealth / Bethesda North Hospital	Cincinnati	Ohio
University Hospitals Cleveland Medical Center	Cleveland	Ohio
Cleveland Clinic Foundation	Cleveland	Ohio
Hillcrest Medical Center	Tulsa	Oklahoma
UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

+ 52 more sites — see the full list on the official registry below.

More Medtronic Cardiovascular trials in the UK

Evolut™ EXPAND TAVR II Pivotal Trial Active, not recruiting

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial Recruiting

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System Active, not recruiting

Endurant CHevAr New Indication Trial: ENCHANT Active, not recruiting

Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial Recruiting

Other trials for the same condition

Hydra Registry - UK Recruiting

SAPIEN 3 Ultra System PMCF Active, not recruiting

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation Enrolling by invitation

ACURATE neo2™ Post Market Clinical Follow up Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04722250 on ClinicalTrials.gov ↗ ← All trials in the UK