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Heart valve clip shows promise for heart failure patients in Real-World study

NCT ID NCT07227675

Disease control Sponsor: Abbott Medical Devices 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called MitraClip in 162 heart failure patients with a leaky mitral valve (mitral regurgitation). The device is clipped onto the valve to reduce leakage. The goal was to see if it is safe and effective in real-world conditions. All patients had severe symptoms despite taking standard heart failure medications.

What this could mean

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

Active substance
MitraClip NT System (a device that clips the mitral valve to reduce leakage)
What this could lead to
If successful, this could provide a safe and effective treatment option for heart failure patients with mitral regurgitation who are not helped by medications alone.
What could go wrong
This is a single-arm registry, not a randomized trial, so results may be less definitive. The device procedure carries risks like bleeding, infection, or valve damage.

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

162 people

The number who actually took part.

Started

Oct 2017

Finished

Mar 2024

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: * Subjects who have national Medicare coverage by CMS * Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology * Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure * Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV * Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject * Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% * Left Ventricular End Systolic Dimension (LVESD) is ≤70 mm Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization * Coronary artery bypass grafting (CABG) within prior 30 days * Percutaneous coronary intervention within prior 30 days * Tricuspid valve disease requiring surgery * Aortic valve disease requiring surgery * Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use * Cerebrovascular accident within prior 30 days * Severe symptomatic carotid stenosis (\> 70% by ultrasound) * Carotid surgery within prior 30 days * Mitral valve orifice area \< 4.0 cm2 * Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip

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Conditions

The condition(s) this trial relates to.

heart failure mitral valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation Mitral valve regurgitation

Contacts and locations

Locations

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75204, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • El Camino Hospital

    Mountain View, California, 94040, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai Medical Center

    Miami, Florida, 33140, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Piedmont Hospital Atlanta

    Atlanta, Georgia, 30309, United States

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Scripps Green Hospital

    La Jolla, California, 92037, United States

  • Seton Medical Center Austin

    Austin, Texas, 78705, United States

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • Stanford Hospital and Clinics

    Stanford, California, 94305, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The heart hospital baylor plano

    Plano, Texas, 75093, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Colorado Hospital

    Denver, Colorado, 80045, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23284, United States

More trials for these conditions

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