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NCT Number: NCT07830888

Mitral Valve Prolapse Arrhythmic Risk

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Rikshospitalet, Oslo University Hospital

Oslo, Norway

Location status: Recruiting

Location contact

Kristina Hermann Haugaa, Professor, MD, PhD

CONTACT

[email protected]

+47 23070000

About this study

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.

The aim of this study is to develop and validate a risk prediction model for severe ventricular arrhythmias in patients with AMVP, with the goal of improving individualized risk stratification and identying patients who may warrant consideration for ICD therapy.

This is a retrospective, multicenter longitudinal cohort study of patients with mitral valve prolapse and ventricular arrhythmias. Baseline characteristics are defined based on the clinical status at the index event and during the subsequent six months. Clinical events occurring six months or more after the index event are considered follow-up events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Risk Prediction Model

Other

A multivariable risk prediction model will be developed and validated to estimate the individual risk of severe ventricular arrhythmias in patients with mitral valve prolapse. The model will be based on clinical, electrocardiographic, arrhythmic, echocardiographic and CMR variables. The risk prediction model is evaluated as part of this observational study and does not constitute a study-specific therapeutic or diagnostic intervention.

Primary outcomes

  1. Severe Ventricular Arrhythmias

    Time frame: From >6 months after baseline until the end of available follow-up, minimum follow-up 6 months

    Occurence of severe ventricular arrhythmias, defined as ventricullar fibrillation, sustained ventricular tachycardia, aborted cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) therapy, occuring more than 1 month after baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Hermann Haugaa, Professor, MD, PhD

CONTACT

[email protected]

+47 23070000

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: MVP-Risk

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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