Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring

NCT06378996 | Recruiting

• 1 other identifier: S68535
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Prolapse; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (4)

• Time to arrhythmic mitral valve prolapse detection

  The number of days to reach the detection of arrhythmic mitral valve prolapse, defined as a PVC burden ≥ 5%, nsVT, VT or VF

  14 days

• Number of days with high PVC-burden ≥5%

  Number of days with a PVC-burden ≥5%

  14 days

• Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)

  Number of days with ≥ 1 nsVT, VT or VF episode

  14 days

• Day-to-day variation in percentage PVC burden

  Day-to-day variation of the absolute number of PVC burden in percentage

  14 days

Secondary Outcomes (4)

• Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI

  14 days

• Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI

  14 days

• Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography

  14 days

• Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography

  14 days

Study Arms (1)

14 day monitoring

EXPERIMENTAL

Diagnostic Test: 14-day rhythm monitoring

Interventions

14-day rhythm monitoring DIAGNOSTIC_TEST

Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.

14 day monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Bert Vandenberk, MD PhD

CONTACT

+3216338686; vandenberkbert@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, interventional cohort study including 3 different patient cohorts: * Cohort 1: Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation * Cohort 2: Patients with AMVP and mild to moderate mitral valve regurgitation * Cohort 3: Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 23, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)