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MRI reveals how MitraClip reshapes the heart

NCT ID NCT02924363

Knowledge-focused Sponsor: Dipan Shah 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 54 people with severe mitral regurgitation who received the MitraClip device. Researchers used heart MRI and ultrasound before, right after, and 6 months after the procedure to see how the heart's shape and function changed. The goal was to understand the heart's remodeling process, not to test a new treatment.

What this could mean

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

Active substance
MitraClip device
What this could lead to
If successful, this study could help doctors understand how MitraClip repairs the heart's shape and function, guiding better treatment for mitral regurgitation.
What could go wrong
This is a small, completed observational study (54 people) that measures changes but does not test a new treatment or prove long-term benefits. Results may not apply to all patients.

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

54 people

The number who actually took part.

Started

Jan 2017

Finished

Dec 2021

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

This is a prospective, multicenter, longitudinal observational study to evaluate reverse cardiac remodeling following MitraClip therapy for significant mitral regurgitation. A schematic overview of the study design is shown in Figure 4. Subjects with 3-4+ mitral regurgitation, who are already scheduled to undergo MitraClip therapy, will be enrolled, if they do not meet any of the exclusion criteria. Patients will undergo CMR and echocardiographic assessment of their mitral regurgitation and cardiac morphology/function prior to MitraClip placement. Patients without contraindication to gadolinium will undergo late gadolinium enhancement CMR to assess for LV and papillary muscle replacement fibrosis, and T1 mapping (pre and post contrast) to assess for LV diffuse interstitial fibrosis.

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. Males or females, 18 years of age or older. 2. Negative pregnancy test (serum or urine β-HCG) within 24 hours of gadolinium contrast administration, if female and of child-bearing potential. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study (this applies only to patients in the gadolinium sub-study). 3. Symptomatic severe mitral regurgitation (grade 3-4+). 4. Undergoing MitraClip implantation due to increased surgical risk. 5. Patients or legally authorized representatives who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements. Exclusion Criteria: 1. The patient is enrolled in the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial (COAPT). 2. The patient is scheduled to undergo percutaneous coronary intervention with MitraClip procedure. 3. The patient has Stage D Congestive Heart Failure or inability to lay flat for 60 minutes. 4. The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. 5. The patient has contraindications to CMR, including: 1. Implanted defibrillator or pacemaker that is not MRI conditional 2. Epicardial pacemaker leads, or any abandoned leads 3. Ferromagnetic aneurysm clip 4. Ferromagnetic halo device 5. Cochlear implants 6. Implanted infusion pumps 7. Severe claustrophobia 8. Any other conditions which represent contraindication to CMR. 6. The patient is clinically unstable

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

More trials for these conditions

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