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RECRUITING
NCT06378996
NA

Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

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.

Official title: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-05-01

Completion Date

2026-03

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

14-day rhythm monitoring

Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.

Locations (1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium