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Heart valve showdown: which TAVR device wins for small aortas?

NCT ID NCT04722250

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of TAVR devices (self-expanding vs. balloon-expandable) in over 1,100 people with severe aortic stenosis and a small aortic annulus. The goal is to see which device leads to fewer deaths, strokes, or hospitalizations, and which performs better over time. Participants are randomly assigned to receive one of the two devices.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcatheter aortic valve replacement (TAVR) devices: Medtronic Evolut (self-expanding) or Edwards SAPIEN (balloon-expandable)
What this could lead to
If this trial succeeds, it could show which TAVR device is safer and more effective for people with small aortic valves, leading to better long-term outcomes and fewer complications.
What could go wrong
This is a large trial, but results may not apply to all patients. Both devices have risks like stroke, blood clots, or valve problems. The study compares two approved devices, so no new treatment is being discovered.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,103 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve replacement Aortic valve stenosis Symptomatic aortic stenosis

Contacts and locations

Locations

  • AOU Integrata Verona

    Verona, Italy

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

  • AscensionVia Christi St. Francis Hospital

    Wichita, Kansas, 67226, United States

  • Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

    Pisa, Italy

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital

    Dallas, Texas, 75226, United States

  • Baylor Saint Luke's Hospital

    Houston, Texas, 77030, United States

  • Buffalo General Medical Center

    Buffalo, New York, 14203, United States

  • CHU Bordeaux

    Pessac, France

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, France

  • Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz

    Carnaxide, Portugal

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinique Pasteur

    Toulouse, France

  • Deutsches Herzzentrum Berlin

    Berlin, Germany

  • Deutsches Herzzentrum Munchen

    München, Germany

  • Emory Structural Heart Clinic and Emory University Midtown

    Atlanta, Georgia, 30308, United States

  • HagaZiekenhuis - Locatie Leyweg

    The Hague, Netherlands

  • HealthPark Medical Center

    Fort Myers, Florida, 33908, United States

  • Helios Health Institute GmbH

    Leipzig, Germany

  • Helsinki University Hospital

    Helsinki, Finland

  • Hers-und Diabeteszentrum NRW - Ruhr -Universitati Bochum

    Bad Oeynhausen, Germany

  • Hillcrest Medical Center

    Tulsa, Oklahoma, 74104, United States

  • Hospital Vall d'Hebron

    Barcelona, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Inselspital - Universitätsspital Bern

    Bern, Switzerland

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • J.W. Ruby Memorial Hospital/West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Kath. St.-Johannes-Gesellschaft Dortmund gGmbH - St. Johannes-Hospital Dortmund

    Dortmund, Germany

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 91360, United States

  • Maastricht Universitair Medisch Centrum (MUMC)

    Maastricht, Netherlands

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mission Hospital

    Asheville, North Carolina, 28801, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • NorthShore Health Systems

    Evanston, Illinois, 60201, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309, United States

  • Policlinico Sant' Orsala - Malpighi

    Bologna, Italy

  • Providence Health-St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Rigshospitalet

    Copenhagen, Denmark

  • Royal Infirmary of Edinburgh

    Edinburgh, United Kingdom

  • Saint George Regional Hospital

    St. George, Utah, 84770, United States

  • Saint Vincent Heart Center of Indiana

    Carmel, Indiana, 46290, United States

  • Scripps Memorial Hospital

    La Jolla, California, 92037, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Seton Heart Institute

    Austin, Texas, 78705, United States

  • Sheba Medical Center

    Ramat Gan, Israel

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303, United States

  • St. Michaels Hospital/Unity Health Toronto

    Toronto, Ontario, Canada

  • St. Thomas West Hospital

    Nashville, Tennessee, 37205, United States

  • Sutter Health

    San Francisco, California, 94109, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Texas Health Presbyterian Hospital/Dallas

    Dallas, Texas, 76231, United States

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • The Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

    Leeds, United Kingdom

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • TriHealth / Bethesda North Hospital

    Cincinnati, Ohio, 45220, United States

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UNC Memorial Hospital

    Chapel Hill, North Carolina, 27599, United States

  • UPMC Pinnacle Harrisburg

    Harrisburg, Pennsylvania, 17110, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure

    Houston, Texas, 77030, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Universitätsklinikum Düsseldorf

    Düsseldorf, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Germany

  • Victoria Heart Institute Foundation/Royal Jubilee Hospital

    Victoria, British Columbia, Canada

  • WHC Washington MedStar

    Washington D.C., District of Columbia, 20010, United States

  • Weill Cornell Medical Center

    New York, New York, 10065, United States

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

  • York Hospital

    York, Pennsylvania, 17403, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.