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Can imaging and monitoring unlock the hidden dangers of mitral valve prolapse?

NCT ID NCT07103733

Knowledge-focused Sponsor: Annetine Gelijns 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study enrolls adults aged 60 and older who are already participating in a larger trial comparing two ways to repair a leaky mitral valve. Researchers will use heart MRI scans, wearable heart monitors, and tissue samples to look for scarring in the heart muscle and abnormal heart rhythms. The goal is to understand how mitral valve prolapse damages the heart over time, which could lead to better treatments and fewer complications.

What this could mean

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

Active substance
Cardiac magnetic resonance imaging, wearable heart monitoring, and myocardial tissue biopsy
What this could lead to
If this study succeeds, it could reveal why mitral valve prolapse sometimes leads to dangerous heart rhythms and heart failure, helping doctors choose the best repair method for each patient.
What could go wrong
This is an observational substudy, so it cannot prove cause and effect. The findings may not apply to all patients, and some procedures like biopsy carry small risks.

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 250 people

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

Started

Oct 2023

Expected to finish

Jun 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.

Ages

60 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: * Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial. * For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial. Exclusion Criteria: * Severe claustrophobia not controlled with sedation. * Prior adverse reaction to gadolinium administration. * Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging. * Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).

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Conditions

The condition(s) this trial relates to.

mitral valve prolapse ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome

As listed by the trial registrant

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

Left ventricular fibrosis Mitral valve prolapse Ventricular arrhythmias

Contacts and locations

Locations

  • Barts Health NHS Trust

    Whitechapel, London, United Kingdom

  • Cedars-Sinai

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Deutsches Herzzentrum der Charité

    Berlin, 13353, Germany

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

  • Herzzentrum Leipzig

    Leipzig, 04289, Germany

  • Keck Hospital of the University of Southern California

    Los Angeles, California, 90033, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • Manchester University NHS Foundation Trust

    Oxford, Manchester, United Kingdom

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital

    New York, New York, 10075, United States

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Royal Papworth Hospital NHS Foundation Trust

    Trumpington, Cambridge, United Kingdom

  • Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons

    Kansas City, Missouri, 64111, United States

  • South Tees Hospitals NHS Foundation Trust

    Marton-in-Cleveland, Middlesbrough, United Kingdom

  • Stanford University

    Stanford, California, 94305, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The Leeds Teaching Hospitals NHS Trust

    Leeds, England, LS9 7TF, United Kingdom

  • University Hospitals Sussex NHS Foundation Trust

    Worthing, West Sussex, BN11 2DH, United Kingdom

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Weill Cornell Medicine/ New York-Presbyterian Hospital

    New York, New York, 10065, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States

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