NCT06378996 Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
| NCT ID | NCT06378996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Mitral Valve Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-05-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06378996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06378996 currently recruiting?
Yes, NCT06378996 is actively recruiting participants. Contact the research team at vandenberkbert@gmail.com for enrollment information.
Where is the NCT06378996 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06378996 clinical trial?
NCT06378996 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 60 participants.