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

New heart valve replacement could offer hope for patients with severe tricuspid leak

NCT ID NCT04482062

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device called EVOQUE that replaces the tricuspid valve in people with severe leakage (tricuspid regurgitation). The goal is to see if it is safe and can reduce leakage, improve symptoms, and enhance quality of life compared to standard medical therapy alone. About 864 adults with severe tricuspid regurgitation are participating.

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

864 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Jun 2030

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: * Age ≥ 18 years old * Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance. * Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification) * The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement * Patient is willing and able to comply with all study evaluations and provides written informed consent. Exclusion Criteria: * Anatomy precluding proper device delivery, deployment and/or function * LVEF \< 25% * Evidence of severe right ventricular dysfunction * Any of the following pulmonary pressure parameters: 1. PASP \>60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg) 2. PASP \>70 mmHg by RHC 3. PVR \>5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP \>85 mmHg after vasodilator challenge) * Previous tricuspid surgery or intervention * Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following: 1. Implanted in the RV within the last90 days 2. Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option 3. Has delivered appropriate ICD therapy * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation. * Active endocarditis within the last 90 days or infection requiring antibiotic therapy (oral or intravenous) within the last 14 days * Hemodynamically significant pericardial effusion * Significant intra-cardiac mass, thrombus, or vegetation. * Clinically significant, untreated coronary artery disease requiring revascularization, evidence of acute coronary syndrome, recent myocardial infarction within the last 30 days. * Any of the following cardiovascular procedures: 1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days 2. Carotid surgery within the last 30 days 3. Direct current cardioversion within the last 30 days 4. Leadless RV pacemaker implant within the last 30 days 5. Cardiac surgery within the last 90 days * Known history of untreated severe symptomatic carotid stenosis (\>50% by ultrasound) or asymptomatic carotid stenosis (\>70% by ultrasound) * Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365days), or any planned percutaneous cardiac procedure within the next 90 days * Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days * Patient with refractory heart failure requiring or which required advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA/ESC/EACTS Stage D heart failure) * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months (180 days) * Stroke within the last 90 days * Modified Rankin Scale ≥ 4 disability * Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73m2 or requiring chronic renal replacement therapy. * Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C * Patient is oxygen-dependent or requires continuous home oxygen * Chronic anemia with transfusion dependency or Hgb \< 9 g/dL not corrected by transfusion * Unable to walk at least 100 meters in a 6-minute walk test * Thrombocytopenia (Platelet count \< 75,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) * Known bleeding or clotting disorders or patient refuses blood transfusion * Active gastrointestinal (GI) bleeding within the last 90 days * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days). * Patients in whom (any of the following): 1. TEE is contraindicated or cannot be completed 2. tricuspid valve anatomy is not evaluable by TTE or TEE * In the opinion of the investigator, access to and through the femoral vein/IVC with a guide sheath and delivery catheter is deemed not feasible (e.g. occluded femoral veins, occluded or thrombosed IVC filter) * Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media * Currently participating in another investigational biologic, drug or device study * Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \< 12 months (365 days). * Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant uncorrected congenital heart disease (including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV) * Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-ups * Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship * Any patient considered to be vulnerable

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiovascular diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart failure heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

Cardiovascular diseases Heart failure Heart valve diseases Tricuspid valve disease Tricuspid valve insufficiency Tricuspid valve regurgitation

Contacts and locations

Locations

  • Ascension Via Christi St. Francis

    Wichita, Kansas, 67214, United States

  • Baylor Heart Hopsital Plano

    Plano, Texas, 75093, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/NYPH

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Florida Heart & Vascular Care - JFK

    Atlantis, Florida, 33462, United States

  • HCA Houston Healthcare

    Houston, Texas, 77004, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Herz- und Diabeteszentrum NRW, Bad Oeynhausen

    Bad Oeynhausen, 32545, Germany

  • Herzzentrum Dresden Universitätsklinik

    Dresden, 01307, Germany

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289, Germany

  • Herzzentrum Universitätsklinik Bonn

    Bonn, 53105, Germany

  • Herzzentrum der Uniklinik Köln

    Cologne, 50937, Germany

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Klinikum der Universität München - Großhadern

    München, 81377, Germany

  • Lankenau Heart Institute

    Wynnewood, Pennsylvania, 19096, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical Center of the Rockies

    Loveland, Colorado, 80538, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • NCH Heart Institute

    Naples, Florida, 34102, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • Oregon Health & Science University

    Portland, Oregon, 97293, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903, United States

  • SJHMC Heart and Vascular Institute

    Phoenix, Arizona, 85013, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Saint Thomas Health

    Nashville, Tennessee, 37205, United States

  • Scripps Memorial Hospital La Jolla

    La Jolla, California, 92037, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290, United States

  • Stanford University

    Stanford, California, 94305, United States

  • State University of New York at Buffalo

    Buffalo, New York, 14203, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • The Cardiac & Vascular Institute Research Foundation

    Gainesville, Florida, 32605, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Tucson Medical Center

    Tucson, Arizona, 85712, United States

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Michigan Hospital and Health Systems

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Mason Franciscan Health

    Seattle, Washington, 98101, United States

  • Weill Cornell Medicine-New York Presbyterian Hospital

    New York, New York, 10021, United States

More trials for these conditions

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