Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring (ALARM-PILOT)

Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Prolapse; Ventricular Arrythmia
• Intervention / Treatment: Diagnostic test: 14-day rhythm monitoring

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bert Vandenberk, MD PhD; Phone Number: +3216338686; Email: vandenberkbert@gmail.com

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Bert Vandenberk, MD, PhD; Email: bert.vandenberk@uzleuven.be
      • Principal Investigator: Bert Vandenberk, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14 day monitoring	Diagnostic test: 14-day rhythm monitoring; Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI	Correlation analysis of two continuous variables. The PVC burden will be calculated as the number of PVCs divided by the total number of heartbeats during the 14 days rhythm monitoring. Percentage of late gadolinium enhancement will be calculated as the ratio of the mass of myocardial tissue with late gadolinium enhancement over the total LV mass on cardiac MRI.	14 days
Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI	Correlation analysis of two continuous variables. The mean number of nsVT episodes will be calculated as the average of nsVT episoden per day during the 14 days rhythm monitoring. Percentage of late gadolinium enhancement will be calculated as the ratio of the mass of myocardial tissue with late gadolinium enhancement over the total LV mass on cardiac MRI	14 days
Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography	Correlation analysis of two continuous variables. The PVC burden will be calculated as the number of PVCs divided by the total number of heartbeats during the 14 days rhythm monitoring. Global longitudinal strain will be measured using conventional echocardiography on the 2-chamber, 3-chamber, and 4-chamber apical view.	14 days
Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography	Correlation analysis of two continuous variables. Correlation analysis of two continuous variables. The mean number of nsVT episodes will be calculated as the average of nsVT episoden per day during the 14 days rhythm monitoring. Global longitudinal strain will be measured using conventional echocardiography on the 2-chamber, 3-chamber, and 4-chamber apical view.	14 days

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Heart Valve Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: S68535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No