Actively Recruiting
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring - A Pilot Study
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Mitral valve prolapse (MVP) affects up to 3% of people and some with MVP are at risk for dangerous heart rhythm problems called ventricular arrhythmias. This subgroup, called arrhythmic MVP (AMVP), is identified by having MVP, frequent or complex ventricular arrhythmias, and no other heart rhythm causes. Researchers are studying how long-term heart rhythm monitoring can better detect these arrhythmias compared to standard 24-hour tests, aiming to improve diagnosis and plan future studies. Participants will wear a Byteflies patch ambulatory rhythm monitor for 14 days to record their heart rhythms continuously. This device will collect detailed data on premature ventricular contractions (PVCs) and more serious arrhythmias like non-sustained ventricular tachycardia, ventricular tachycardia, or ventricular fibrillation. The study focuses on the variability of these arrhythmias day-to-day and how well long-term monitoring detects arrhythmic MVP. During the study, participants will be monitored using this device for 14 days. Researchers will measure the time to detect arrhythmic MVP, count days with high PVC levels or complex arrhythmias, and assess daily changes in PVC burden. They will also explore links between arrhythmia levels and heart imaging results from MRI and echocardiography. The study starts in May 2024 and continues until June 2026, with no additional treatments involved.
CONDITIONS
Brief 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 653 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)
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 but betablockers
- Known alternative arrhythmic substrate, for example previous myocardial infarction
- Known allergy to adhesives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants undergo 14 days of continuous ambulatory rhythm monitoring using the Byteflies patch to detect arrhythmic mitral valve prolapse.
Continuous monitoring with the patch worn for 14 days
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
B
Bert Vandenberk, MD PhD
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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