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New heart valve procedure could change treatment for aortic stenosis patients

NCT ID NCT02675114

Disease control Sponsor: Edwards Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new, less invasive heart valve (SAPIEN 3) for people with severe aortic stenosis who are at low risk for standard surgery. About 1,000 participants will be randomly assigned to get the new valve or traditional open-heart surgery. The goal is to see if the new valve is as safe and effective, reducing death, stroke, and hospital readmissions.

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

1,000 people

The number who actually took part.

Started

Mar 2016

Expected to finish

Dec 2029

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Severe, calcific aortic stenosis 2. New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) \<50% 3. Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score \< 4 4. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve 2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath 3. Evidence of an acute myocardial infarction ≤ 30 days before randomization 4. Aortic valve is unicuspid, bicuspid, or non-calcified 5. Severe aortic regurgitation (\>3+) 6. Severe mitral regurgitation (\>3+) ≥ moderate stenosis 7. Pre-existing mechanical or bioprosthetic valve in any position 8. Complex coronary artery disease: 1. Unprotected left main coronary artery 2. Syntax score \> 32 3. Heart Team assessment that optimal revascularization cannot be performed 9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization 10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states 11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization 12. Hypertrophic cardiomyopathy with obstruction 13. Ventricular dysfunction with LVEF \< 30% 14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 15. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure 16. Stroke or transient ischemic attack within 90 days of randomization 17. Renal insufficiency and/or renal replacement therapy at the time of screening. 18. Active bacterial endocarditis within 180 days of randomization 19. Severe lung disease or currently on home oxygen 20. Severe pulmonary hypertension 21. History of cirrhosis or any active liver disease 22. Significant frailty as determined by the Heart Team 23. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement 24. Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation 25. Patient refuses blood products 26. Body mass index \> 50 kg/m2 27. Estimated life expectancy \< 24 months 28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication 29. Immobility that would prevent completion of study procedures 30. Patient is not a candidate for both arms of the study 31. Currently participating in an investigational drug or another device study.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiovascular disorder heart disorder

As listed by the trial registrant

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

Aortic stenosis

Contacts and locations

Locations

  • Albany

    Albany, New York, 12208, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Auckland City Hospital

    Grafton, Auckland, 1024, New Zealand

  • Austin Heart

    Austin, Texas, 78756, United States

  • Banner University Medical Center

    Phoenix, Arizona, 85006, United States

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120, United States

  • Barnes-Jewish Hospital / Washington University

    St Louis, Missouri, 63110, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226, United States

  • Carolina's Health System

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Central Maine Medical Center

    Auburn, Maine, 04210, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Cornell University

    New York, New York, 10021, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fairfax INOVA

    Falls Church, Virginia, 22042, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Florida Hospital

    Orlando, Florida, 32803, United States

  • Hartford

    Hartford, Connecticut, 06102, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hoag Hospital

    Newport Beach, California, 92663, United States

  • Intermountain Medical Center

    Salt Lake City, Utah, 84157, United States

  • JFK Medical Center / Atlantic Clinical Research Collaborative

    Atlantis, Florida, 33462, United States

  • Kaiser Permanente San Francisco

    San Francisco, California, 94115, United States

  • Keio University

    Shinjuku, Tokyo, 160-8582, Japan

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical City Dallas Hospital

    Dallas, Texas, 75230, United States

  • Mills/Peninsula Health Services

    Burlingame, California, 94010, United States

  • Morristown Medical Center / Atlantic Health System Hospital

    Morristown, New Jersey, 07962, United States

  • Mount Carmel Health System

    Columbus, Ohio, 43213, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • NYU Medical Center

    New York, New York, 10016, United States

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526, United States

  • Newark Beth Israel

    Newark, New Jersey, 07112, United States

  • NorthShore University HealthSystem Research Institute

    Evanston, Illinois, 60201, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120, United States

  • Osaka University

    Suita, Osaka, 565-0871, Japan

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701, United States

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225, United States

  • Rex Hospital / NC Heart and Vascular Research

    Raleigh, North Carolina, 27607, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Luke's Hospital of Kansas City Mid America

    Kansas City, Missouri, 64111, United States

  • Saint Paul's Hospital

    Vancouver, Canada

  • Saint Thomas Health Services

    Nashville, Tennessee, 37205, United States

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873, Japan

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507, United States

  • Stanford Hospital and Clinics

    Palo Alto, California, 94305, United States

  • Sutter Health Sacramento

    Sacramento, California, 95816, United States

  • Teikyo University

    tabashi City, Tokyo, 173-8606, Japan

  • The Christ Hospital, Cincinnati

    Cincinnati, Ohio, 45219, United States

  • The Heart Hosptial Baylor Plano

    Plano, Texas, 75093, United States

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • UC Health Northern Colorado/Medical Center of the Rockies

    Loveland, Colorado, 80538, United States

  • UPR - Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112, United States

  • UPR - Novant Health Heart and Vascular Institution

    Charlotte, North Carolina, 28204, United States

  • UPR-Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • University of Alabama

    Birmingham, Alabama, 35294, United States

  • University of Buffalo

    Buffalo, New York, 14203, United States

  • University of California, Los Angeles/Ronald Reagan Medical Center

    Los Angeles, California, 90095, United States

  • University of Florida, Gainesville

    Gainesville, Florida, 32610, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia

    Charlottesville, Virginia, 22904, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

  • Winthrop-University Hospital

    Mineola, New York, 11501, United States

  • York Hospital

    York, Pennsylvania, 17403, United States

More trials for these conditions

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