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NCT07830888From ClinicalTrials.govRecruiting

Mitral Valve Prolapse Arrhythmic Risk

Development and Validation of Risk Prediction Model for Severe Ventricular Arrhythmias in Patients With Mitral Valve Prolapse

  • Mitral Valve Prolapse
  • Ventricular Arrhythmias and Cardiac Arrest

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Oslo University Hospital
Enrolment target
500
Started
7 August 2026
Main results due
September 2035
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • No age limit is stated.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* MVP according to the ESC definition AND
* 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

\- Follow up \>6 months

Exclusion Criteria:

* VT/VF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter)
* History of myocardial infarction
* Obstructive coronary diseases - ≥50 % stenosis that was not treated
* History of coronary artery bypass surgery
* Significant valve disease other than MVP - rheumatic heart disease, severe aortic stenosis
* LGE suggestive of probable myocarditis as the etiology.
* Primary inherited arrhythmia - Brugada syndrome, short QT, long QT, CPVT
* Carrier of disease causing mutation known to be associated with arrhythmia even when phenotype is negative (e.g. Lamin A/C)
* Sustained ventricular arrhythmia clearly caused by a reversable cause

What this study is about

In the sponsor’s own words, from the registry.

Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.

Study sites(1)

  • Rikshospitalet, Oslo University Hospital

    Oslo, Norway

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07830888. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Mitral Valve Prolapse Arrhythmic Risk | Trialion