RecruitingNot ApplicableNCT06378996

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

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

60 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

DIAGNOSTIC_TEST14-day rhythm monitoring

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


Locations(1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT06378996


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