Actively Recruiting
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
- New York Heart Association classification 3 or higher 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 such as known allergy to adhesives
You will not qualify if you...
- 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 except beta blockers
- Known alternative arrhythmic substrate, such as previous myocardial infarction
- Known allergy to adhesives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
B
Bert Vandenberk, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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