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New device aims to plug leaky heart valve in heart failure patients

NCT ID NCT03142152

Disease control Sponsor: Cardiac Dimensions, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a device called the Carillon Mitral Contour System in 300 people with heart failure and a leaky mitral valve. The device is placed in a vein to help the valve close better, reducing blood backflow. The goal is to see if it improves symptoms, walking ability, and reduces hospital stays compared to a sham procedure.

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 300 people

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

Started

Jan 2018

Expected to finish

Dec 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: 1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity 2. NYHA II, III, or IV 3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters 4. Left Ventricular Ejection Fraction ≤ 50% 5. LVEDD: * ≥ 55 mm (women) * ≥ 57 mm (men) 6. LVESD ≤ 75 mm 7. Corrected NT-proBNP \> 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent. 8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee 9. Age ≥ 18 years old 10. Carillon implant can be sized and placed in accordance with the IFU 11. The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent Exclusion Criteria: 1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device 2. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture) 3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement 4. Severe mitral annular calcification 5. Severe aortic stenosis 6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year 7. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study * An entire list of eligibility is available in the clinical investigational plan

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart failure heart valve disorder mitral valve insufficiency

As listed by the trial registrant

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

Cardiovascular diseases Functional mitral regurgitation Heart diseases Heart failure Heart valve diseases Mitral valve insufficiency

How to take part

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

  1. The places running it

    65 sites in 8 countries. 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

  • AZ Heart Rhythm

    WITHDRAWN

    Phoenix, Arizona, 85016, United States

  • Advent Health Hospital

    RECRUITING

    Orlando, Florida, 32803, United States

  • Advocate Aurora Research Institute

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Advocate Good Samaritan

    RECRUITING

    Downers Grove, Illinois, 60515, United States

  • Albany Medical College,

    TERMINATED

    Albany, New York, 12208, United States

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension St. Marys Research Institute

    TERMINATED

    Saginaw, Michigan, 48601, United States

  • Augusta University Research Institute

    TERMINATED

    Augusta, Georgia, 30912, United States

  • Banner Health - Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Banner University Tuscon

    RECRUITING

    Tucson, Arizona, 85724, United States

  • Baptist Hospital of Miami

    TERMINATED

    Miami, Florida, 33176, United States

  • Beth Israel Deaconess

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cardiovascular Institute South

    RECRUITING

    Houma, Louisiana, 70360, United States

  • Carilion Hospital

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Carle Foundation Hospital

    TERMINATED

    Urbana, Illinois, 61801, United States

  • Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • CentraCare Heart and Vascular

    RECRUITING

    Saint Cloud, Minnesota, 57584, United States

  • Centre Hospitalier Universitaire De Lille

    WITHDRAWN

    Lille, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinique du Millènaire Montpelier

    RECRUITING

    Montpellier, France

  • Community Health Network

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • Deborah Heart & Lung

    RECRUITING

    Browns Mills, New Jersey, 08015, United States

  • Delray Medical Center

    TERMINATED

    Delray Beach, Florida, 33484, United States

  • Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • European Interbalkan Medical Center

    RECRUITING

    Thessaloniki, Greece

  • Geisinger Medical Center

    ACTIVE_NOT_RECRUITING

    Danville, Pennsylvania, 17822, United States

  • HCA Chippenham Medical Center

    RECRUITING

    Richmond, Virginia, 23225, United States

  • Hackensack University Medical Center

    RECRUITING

    Edison, New Jersey, 07601, United States

  • Harrington Vascular

    TERMINATED

    Cleveland, Ohio, 44106, United States

  • Henrico Doctors Hospital

    RECRUITING

    Henrico, Virginia, 23229, United States

  • Hospital 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Clinic de Barcelona

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Houston Healthcare Medical Center

    RECRUITING

    Houston, Texas, 77004, United States

  • Hôpital Cardiologique Louis Pradel

    RECRUITING

    Lyon, France

  • Hôpital Européen Georges-Pompidou

    WITHDRAWN

    Paris, France

  • Intermountain Medical Center

    TERMINATED

    Salt Lake City, Utah, 84111, United States

  • Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Keck School of Medicine of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • Kettering Health Research Institute

    RECRUITING

    Dayton, Ohio, 45459, United States

  • Lankenau Institute of Medical Research

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Lindner Research Center at the Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02145, United States

  • Medstar

    TERMINATED

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

  • Memorial Care Hospital

    TERMINATED

    Long Beach, California, 90806, United States

  • Methodist Le Bonheur Healthcare

    WITHDRAWN

    Memphis, Tennessee, 38104, United States

  • Midwest Cardiovascular Institute (MCI)

    RECRUITING

    Naperville, Illinois, 60540, United States

  • North Central Heart-Avera

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Northwell Staten Island

    RECRUITING

    New York, New York, 11030, United States

  • Ochsner Health System

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Oklahoma Heart Institute Hospital

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97225, United States

  • Palm Beach Gardens Medical

    RECRUITING

    Palm Beach, Florida, 33410, United States

  • Penn Medicine Lancaster General Health

    RECRUITING

    Lancaster, Pennsylvania, 17602, United States

  • Pole Sante Republique

    RECRUITING

    Clermont-Ferrand, France

  • Policinico Umbeto I

    NOT_YET_RECRUITING

    Roma, Italy

  • Poznan University of Medical Sciences

    RECRUITING

    Poznan, Poland, 61-485, Poland

  • Prairie Heart Institute

    TERMINATED

    Springfield, Illinois, 62701, United States

  • Providence Heart Institute

    RECRUITING

    Portland, Oregon, 97225, United States

  • Rochester Regional Hospital

    RECRUITING

    Rochester, New York, 14621, United States

  • Rush University Medical Center

    TERMINATED

    Chicago, Illinois, 60612, United States

  • Saint Francis Hospital,

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • Scripps Health

    RECRUITING

    San Diego, California, 92037, United States

  • Sentara Norfolk General Hospital

    WITHDRAWN

    Norfolk, Virginia, 23507, United States

  • South Denver Cardiology

    RECRUITING

    Littleton, Colorado, 80210, United States

  • St Boniface Hospital - University of Manitoba

    RECRUITING

    Winnipeg, Manitoba, Canada

  • St Elizabeth's Medical Center

    RECRUITING

    Boston, Massachusetts, 02135, United States

  • St James University Hospital

    RECRUITING

    Leeds, United Kingdom

  • St Michael/Prime Healthcare Services

    RECRUITING

    Newark, New Jersey, 07102, United States

  • St. Louis Heart and Vascular

    RECRUITING

    St Louis, Missouri, 63044, United States

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

  • Tallahassee Research Institute

    ACTIVE_NOT_RECRUITING

    Tallahassee, Florida, 32308, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    WITHDRAWN

    Philadelphia, Pennsylvania, 19107, United States

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Tucson Medical Center Health

    RECRUITING

    Tucson, Arizona, 85712, United States

  • UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UPMC Pinnacle Hospitals

    RECRUITING

    Mechanicsburg, Pennsylvania, 17050, United States

  • Unity Health Toronto, St Michael's Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • University Clinical Hospital of Valladolid

    NOT_YET_RECRUITING

    Valladolid, Spain

  • University at Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Alberta

    WITHDRAWN

    Edmonton, Alberta, Canada

  • University of California- San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Miami

    TERMINATED

    Miami, Florida, 33136, United States

  • University of Michigan

    TERMINATED

    Ann Arbor, Michigan, 48859, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19014, United States

  • University of Pittsburgh Medical Center

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Virginia Health System

    WITHDRAWN

    Charlottesville, Virginia, 22903, United States

  • Università Federico Naples

    RECRUITING

    Naples, Italy

  • Vassar Brothers- Hudson Valley Cardiovascular Practice

    RECRUITING

    Poughkeepsie, New York, 12601, United States

  • Wellstar Health System,

    TERMINATED

    Marietta, Georgia, 30062, United States

  • William Beaumont Hospital

    WITHDRAWN

    Royal Oak, Michigan, 48073, United States

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