Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a simple valve fix beat waiting for heart patients?

NCT ID NCT04889872

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 approaches for people aged 65+ with moderate aortic stenosis (a narrowed heart valve): either getting a new valve placed through a thin tube (TAVR) or just having regular check-ups. The goal is to see if early treatment prevents death or heart failure better than waiting. About 2,250 participants will be followed for at least two years.

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

About 2,250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Jun 2037

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

65 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.

Key Inclusion Criteria: 1. 65 years of age or older at time of randomization 2. Moderate aortic stenosis 3. Subject has symptoms or evidence of cardiac damage/dysfunction 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system 3. Aortic valve is unicuspid or non-calcified 4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification 5. Pre-existing mechanical or bioprosthetic aortic valve 6. Severe aortic regurgitation 7. Prior balloon aortic valvuloplasty to treat severe AS 8. LVEF \< 20% 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic stenosis, calcific are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

aortic valve disease 1 aortic valve stenosis Aortic Valve, Calcification of

As listed by the trial registrant

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

Aortic stenosis, calcific Aortic valve stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    50 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMC Amsterdam

    ACTIVE_NOT_RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Alexian Brothers Hospital

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Allegheny Singer Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Texas Cardiovascular

    RECRUITING

    Austin, Texas, 78705, United States

  • Ascension Via Christi St. Francis

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Atlantic Health System Hospital Corp - Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Baptist Health Research Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Baptist Memorial Hospital Memphis

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Bay Area Structural Heart at Sutter Health

    RECRUITING

    San Francisco, California, 94109, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • CentraCare Heart and Vascular Center

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Columbia University Irving Medical Center/NYPH

    ACTIVE_NOT_RECRUITING

    New York, New York, 10032, United States

  • Eisenhower Desert Cardiology Center

    RECRUITING

    Rancho Mirage, California, 92270, United States

  • Emory University Atlanta

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Erasmus Rotterdam

    ACTIVE_NOT_RECRUITING

    Rotterdam, South Holland, 3015, Netherlands

  • Flinders Medical Centre

    ACTIVE_NOT_RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • HCA Houston Healthcare Medical Center

    RECRUITING

    Houston, Texas, 77004, United States

  • Hamiton Health Services

    ACTIVE_NOT_RECRUITING

    Hamilton, Onterio, L8L 2X2, Canada

  • Heart Center LLC, Huntsville

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • Huntington Hospital

    WITHDRAWN

    Pasadena, California, 91105, United States

  • Hôpitaux Universitaire de Genève

    ACTIVE_NOT_RECRUITING

    Geneva, 1205, Switzerland

  • Jersey Shore University Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Kaiser Mid Atlantic

    RECRUITING

    McLean, Virginia, 22102, United States

  • Kaiser Permanente Northwest

    ACTIVE_NOT_RECRUITING

    Clackamas, Oregon, 97015, United States

  • Kaiser San Francisco Medical Center

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94118, United States

  • Keio University Hospital

    ACTIVE_NOT_RECRUITING

    Shinjuku, Tokyo, 160-8582, Japan

  • Kokura Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Fukuoka, Kyushu, 802-8555, Japan

  • Lankenau Medical Center

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Legacy Emanuel Medical Center

    RECRUITING

    Portland, Oregon, 97227, United States

  • Leiden Universitair Medisch Centrum

    ACTIVE_NOT_RECRUITING

    Leiden, South Holland, 2333, Netherlands

  • Louisiana State University

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Mary Hitchcock Memorial Hospital

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Massachusetts General Hospital Boston

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Methodist Hospital of San Antonio

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229, United States

  • Methodist Le Bonheur Healthcare

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Minneapolis Heart Institue, St. Paul's

    RECRUITING

    Minneapolis, Minnesota, 55102, United States

  • Monash Health

    ACTIVE_NOT_RECRUITING

    Clayton, Victoria, 3168, Australia

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Moses Cone Memorial Hospital

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • Mount Carmel Health System

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43213, United States

  • NYU Langone Health

    WITHDRAWN

    New York, New York, 10016, United States

  • NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • Ochsner Clinical Foundation

    ACTIVE_NOT_RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Oklahoma Heart Institute

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Parkwest Medical Center

    RECRUITING

    Knoxville, Tennessee, 37923, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pinnacle Health Harrisburg

    ACTIVE_NOT_RECRUITING

    Wormleysburg, Pennsylvania, 17043, United States

  • Providence Heart & Vascular Institute Portland

    WITHDRAWN

    Portland, Oregon, 97225, United States

  • Rochester General Hospital

    RECRUITING

    Rochester, New York, 14621, United States

  • Royal Adelaide Hospital

    ACTIVE_NOT_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Rutgers Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Saint Alphonsus

    RECRUITING

    Boise, Idaho, 83704, United States

  • Saint Luke's Hospital of Kansas City Mid America

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Saint Thomas Health

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Sakakibara Heart Institute

    ACTIVE_NOT_RECRUITING

    Fuchū, Tokyo, 183-0003, Japan

  • Santa Barbara Cottage Hospital

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sendai Kousei Hospital

    ACTIVE_NOT_RECRUITING

    Sendai, Miyagi, 981-0914, Japan

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • St. Francis Hospital

    RECRUITING

    Roslyn, New York, 11576, United States

  • St. Patrick Hospital

    ACTIVE_NOT_RECRUITING

    Missoula, Montana, 59802, United States

  • St. Paul's Hospital

    ACTIVE_NOT_RECRUITING

    Vancouver, British Columbia, V6E1M7, Canada

  • Stanford Univeristy

    RECRUITING

    Stanford, California, 94305, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98112, United States

  • The Cardiac & Vascular Institute Research Foundation

    WITHDRAWN

    Gainesville, Florida, 32605, United States

  • The Christ Hospital

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • The Prince Charles Hospital

    ACTIVE_NOT_RECRUITING

    Chermside, Queensland, 4032, Australia

  • The University of Texas Health Science Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The Valley Hospital

    RECRUITING

    Ridgewood, New Jersey, 07450, United States

  • Tucson Medical Center

    ACTIVE_NOT_RECRUITING

    Tucson, Arizona, 85712, United States

  • UC Health Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • UPMC Presbyterian Shadyside

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Buffalo Kaleida Health

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • Universitätsspital Zürich

    WITHDRAWN

    Zurich, 8091, Switzerland

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Yale Universtiy

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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