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

NCT ID: NCT06378996

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

14 day monitoring

Group Type: EXPERIMENTAL

14-day rhythm monitoring

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

14-day rhythm monitoring

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years or older
• Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
• New York Heart association classification ≥3 for cohort 3 and classification 1 or 2 for cohorts 1 and 2
• Willing and able to provide signed written informed consent
• No contra-indication for long-term monitoring (known allergy to adhesives)

Exclusion Criteria

• Prior cardiac surgery, including previous mitral valve intervention
• Prior endovascular mitral valve repair (MitraClip)
• Previous catheter ablation of ventricular arrhythmias
• Patients not in sinus rhythm
• Patients on anti-arrhythmic drugs but betablockers
• Known alternative arrhythmic substrate, for example previous myocardial infarction
• Known allergy to adhesives

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Bert Vandenberk, MD PhD

Role: CONTACT

vandenberkbert@gmail.com

+3216338686

Facility Contacts

Bert Vandenberk, MD, PhD

Role: primary

bert.vandenberk@uzleuven.be

Other Identifiers

S68535

Identifier Type: -

Identifier Source: org_study_id