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Can a new risk score predict deadly heart rhythms in mitral valve prolapse?

NCT ID NCT07830888

NEW Diagnosis Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Mitral valve prolapse is common and usually harmless, but a small group of patients develop dangerous heart rhythms that can cause sudden cardiac arrest. Researchers at Oslo University Hospital are building and testing a risk prediction model that combines clinical exams, electrocardiograms, heart imaging and cardiac MRI to estimate each patient's individual risk. The study follows about 500 people with mitral valve prolapse and some arrhythmia burden for at least six months to see who develops severe ventricular arrhythmias. The goal is to help doctors decide who might benefit from closer monitoring or an implantable defibrillator.

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 the model works, doctors could better identify which people with mitral valve prolapse face dangerous heart rhythms and may need closer monitoring or a defibrillator.
What could go wrong
This is an observational study that builds a statistical model, not a treatment. The model may not predict accurately in other hospitals or patient groups, and it cannot prove that acting on its predictions saves lives.

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 500 people

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

Started

Aug 2026

Expected to finish

Sep 2035

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

Mitral Valve Prolapse with Ventricular Arrhythmias

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. MVP according to the ESC definition AND 2. Arrhythmic burden of: * A total PVC burden ≥ 0,5 % per day OR * Documentation of NSVT on any modality OR * More severe ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest) that occurred \>1 month after the beginning of follow up. AND 3. Follow up \>6 months Exclusion Criteria: * 1\. VT/VF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter) 2. History of myocardial infarction 3. Obstructive coronary diseases - ≥50 % stenosis that was not treated 4. History of coronary artery bypass surgery 5. Significant valve disease other than MVP - rheumatic heart disease, severe aortic stenosis 6. LGE suggestive of probable myocarditis as the etiology. 7. Primary inherited arrhythmia - Brugada syndrome, short QT, long QT, CPVT 8. Carrier of disease causing mutation known to be associated with arrhythmia even when phenotype is negative (e.g. Lamin A/C) 9. Sustained ventricular arrhythmia clearly caused by a reversable cause

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Conditions

The condition(s) this trial relates to.

cardiac arrest Death, Sudden, Cardiac mitral valve prolapse

As listed by the trial registrant

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

Mitral valve prolapse Ventricular arrhythmias and cardiac arrest

How to take part

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

  1. The places running it

    1 site. 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

  • Rikshospitalet, Oslo University Hospital

    RECRUITING

    Oslo, Norway

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