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

NCT06378996 — Not applicable, Completed, 60 participants, Universitaire Ziekenhuizen KU Leuven

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

Registry	NCT06378996, acronym ALARM-PILOT
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	60 (Actual)
Sponsor	Universitaire Ziekenhuizen KU Leuven (Other)
Conditions	Mitral Valve Prolapse, Ventricular Arrythmia
Interventions	14-day rhythm monitoring (Diagnostic test)
Dates	start 2024-05-01, primary completion 2026-06-15, completion 2026-06-15, first posted 2024-04-23, last updated 2026-07-21
Locations	1 site in Belgium

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
14 day monitoring	Experimental	Diagnostic Test: 14-day rhythm monitoring

14-day rhythm monitoring (Diagnostic test): Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.

+Outcome measures

Primary outcomes

Time to arrhythmic mitral valve prolapse detection [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
Number of days with high PVC-burden ≥5% [14 days]: Number of days with a PVC-burden ≥5%
Number of days with complex ventricular arrhythmia (nsVT, VT, or VF) [14 days]: Number of days with ≥ 1 nsVT, VT or VF episode
Day-to-day variation in percentage PVC burden [14 days]: Day-to-day variation of the absolute number of PVC burden in percentage

Secondary outcomes

Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI [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.
Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI [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
Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography [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.
Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
UZ Leuven	Leuven, Vlaams-Brabant	Belgium