Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring (ALARM-PILOT)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Ventricular Arrythmia; Mitral Valve Prolapse

Treatments: Diagnostic Test: 14-day rhythm monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06378996

S68535

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older
• Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
• New York Heart association classification ≥3
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

14 day monitoring

Experimental group

Treatment:

Diagnostic Test: 14-day rhythm monitoring