protocolSection identificationModule nctId: NCT06378996, orgStudyIdInfo id: S68535, briefTitle: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring, acronym: ALARM-PILOT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry., conditionsModule conditions: Mitral Valve Prolapse, conditions: Ventricular Arrythmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, single arm, interventional cohort study including 3 different patient cohorts:* Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation* Patients with AMVP and mild to moderate mitral valve regurgitation* Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 14-day rhythm monitoring, outcomesModule primaryOutcomes measure: Time to arrhythmic mitral valve prolapse detection, primaryOutcomes measure: Number of days with high PVC-burden ≥5%, primaryOutcomes measure: Number of days with complex ventricular arrhythmia (nsVT, VT, or VF), primaryOutcomes measure: Day-to-day variation in percentage PVC burden, secondaryOutcomes measure: Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI, secondaryOutcomes measure: Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI, secondaryOutcomes measure: Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography, secondaryOutcomes measure: Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Bert Vandenberk, MD, PhD, role: CONTACT, email: bert.vandenberk@uzleuven.be, contacts name: Bert Vandenberk, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False