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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 14-day rhythm monitoring

Treatment groups

60 Participants
are divided into 1 treatment group