Detecting arrhythmias in patients with mitral valve prolapse using long-term monitoring
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study
This study is testing if a longer 14-day heart rhythm monitoring can help find dangerous heartbeats in people with mitral valve prolapse better than the usual 24-hour monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06378996 on ClinicalTrials.gov |
What this trial studies
This pilot study focuses on patients with mitral valve prolapse (MVP) who are at risk for ventricular arrhythmias, a condition known as arrhythmic MVP. The study aims to improve diagnostic accuracy by utilizing 14-day long-term rhythm monitoring instead of the traditional 24-hour Holter monitoring. By capturing a more comprehensive rhythm profile, the study seeks to identify patients with significant arrhythmia burdens that may otherwise go undetected. The goal is to enhance the understanding of arrhythmias associated with MVP and improve patient management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a confirmed diagnosis of mitral valve prolapse and a New York Heart Association classification of 3 or higher.
Not a fit: Patients who have undergone prior cardiac surgery or have known alternative arrhythmic substrates may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better detection and management of arrhythmias in patients with mitral valve prolapse, potentially reducing the risk of serious cardiac events.
How similar studies have performed: Other studies have shown that long-term rhythm monitoring can significantly increase diagnostic yield in various cardiac conditions, suggesting a promising approach for this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Bert Vandenberk, MD PhD
- Email: vandenberkbert@gmail.com
- Phone: +3216338686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.