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

U

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Ventricular Arrythmia
Mitral Valve Prolapse

Treatments

Diagnostic Test: 14-day rhythm monitoring

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

14 day monitoring
Experimental group
Treatment:
Diagnostic Test: 14-day rhythm monitoring

Trial contacts and locations

1

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Central trial contact

Bert Vandenberk, MD PhD

Data sourced from clinicaltrials.gov

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