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Completed

NCT Number: NCT06378996

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

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.

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Key information

Conditions

Mitral Valve Prolapse Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heart Valve Prolapse Ventricular Arrythmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14-day rhythm monitoring

Diagnostic Test

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

Primary outcomes

  1. Time to arrhythmic mitral valve prolapse detection

    Time frame: 14 days

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

  2. Number of days with high PVC-burden ≥5%

    Time frame: 14 days

    Number of days with a PVC-burden ≥5%

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

    Time frame: 14 days

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

  4. Day-to-day variation in percentage PVC burden

    Time frame: 14 days

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

Secondary outcomes

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

    Time frame: 14 days

    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.

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

    Time frame: 14 days

    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

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

    Time frame: 14 days

    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.

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

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: ALARM-PILOT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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