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MRI scans may predict who benefits from MitraClip heart valve repair

NCT ID NCT07131631

Knowledge-focused Sponsor: Minneapolis Heart Institute Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will use cardiac MRI scans to measure heart muscle scarring in 125 people with heart failure and a leaky mitral valve who are scheduled for a MitraClip procedure. Researchers want to see if the amount of scarring predicts how well the heart recovers six months later. Participants will have an MRI before the procedure and again at six months, along with questionnaires about their symptoms.

What this could mean

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

What this could lead to
If successful, this study could help doctors predict which patients will benefit most from the MitraClip procedure, leading to better treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. It will not test a new therapy, and results may not change current practice immediately.

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.

Participants

About 125 people

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

Started

Mar 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation.

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\. Adult patients (≥ 18 years old) with heart failure and reduced ejection fraction (LVEF \< 50% defined by echocardiography), medically and device-optimized according to guidelines, with significant FMR undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA) Exclusion Criteria: 1. Concomitant PCI and TEER 2. Congenital heart disease 3. Stage D heart failure 4. Uncontrolled atrial fibrillation 5. Pregnancy 6. \> moderate tricuspid regurgitation 7. \>moderate aortic regurgitation or stenosis 8. Contraindications or unable to undergo CMR 9. Prior mitral valve repair or replacement

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Conditions

The condition(s) this trial relates to.

heart failure mitral valve insufficiency systolic heart failure

As listed by the trial registrant

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

Functional mitral regurgitation Heart failure and reduced ejection fraction

How to take part

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

  1. The places running it

    6 sites in 2 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

  • Cleveland Clinic

    ENROLLING_BY_INVITATION

    Cleveland, Ohio, 44195, United States

  • IRCCS Ospedale San Raffaele

    ENROLLING_BY_INVITATION

    Milan, 20132, Italy

  • Inova Fairfax Medical Campus

    ENROLLING_BY_INVITATION

    Falls Church, Virginia, 22042, United States

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Sanger Heart and Vascular Institute

    ENROLLING_BY_INVITATION

    Charlotte, North Carolina, 28204, United States

  • The Christ Hospital Health Network

    ENROLLING_BY_INVITATION

    Cincinnati, Ohio, 45219, United States

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