Clinical trial NCT06378996: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
Official title: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Prolapse
Ventricular Arrythmia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single arm, interventional cohort study including 3 different patient cohorts:

* Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation
* Patients with AMVP and mild to moderate mitral valve regurgitation
* Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention
Primary purpose: DIAGNOSTIC

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
* 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

Primary outcomes:
measure: Time to arrhythmic mitral valve prolapse detection
timeFrame: 14 days
measure: Number of days with high PVC-burden ≥5%
timeFrame: 14 days
measure: Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
timeFrame: 14 days
measure: Day-to-day variation in percentage PVC burden
timeFrame: 14 days
Secondary outcomes:
measure: Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI
timeFrame: 14 days
measure: Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI
timeFrame: 14 days
measure: Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography
timeFrame: 14 days
measure: Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography
timeFrame: 14 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
References: