NCT06378996

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Valve Prolapse
• Ventricular Arrythmia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	14-day rhythm monitoring	Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-04-23
• Last updated: 2025-12-05

Locations

1 site across 1 country: Belgium