Rikshospitalet, Oslo University Hospital
Oslo, Norway
Location status: Recruiting
NCT Number: NCT07830888
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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Observational
Oslo, Norway
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
AND
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Oslo University Hospital
Other
Development and Validation of Risk Prediction Model for Severe Ventricular Arrhythmias in Patients With Mitral Valve Prolapse
Acronym: MVP-Risk
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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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