Predicting high-risk arrhythmic events in people with arrhythmic mitral valve prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, multicenter cohort study aiming to develop and validate a risk prediction model for severe ventricular arrhythmias in patients with arrhythmic mitral valve prolapse. Baseline features are collected at the index event and during the following six months, with outcomes tracked from six months onward. The study uses a risk model to refine individual risk stratification and identify candidates for ICD therapy. Participants have MVP with documented arrhythmic burden or severe ventricular arrhythmias and are followed for at least six months, with several exclusion criteria to rule out alternative etiologies of arrhythmia. Lead site is Oslo University Hospital in Oslo, Norway, with no listed collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Rikshospitalet, Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Study coordinator: Kristina Hermann Haugaa, Professor, MD, PhD
• Email: mvp-risk@ous-hf.no
• Phone: +47 23070000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.