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Recruiting
NCT07830888
Mitral Valve Prolapse Arrhythmic Risk
Conditions: Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
Sex: All
Healthy volunteers: No
Enrollment: 500
Sponsor: Oslo University Hospital
Location: Rikshospitalet, Oslo University Hospital Oslo
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07830888). StuddyBuddy aggregates publicly available trial information.