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Search / Trial NCT06378996

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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Apr 18, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how effective long-term heart rhythm monitoring is for detecting ventricular arrhythmias in patients with mitral valve prolapse (MVP). MVP is a condition affecting the heart's mitral valve, and while most people with MVP don't have severe problems, some may experience irregular heartbeats, known as ventricular arrhythmias. The study aims to see if monitoring a patient’s heart rhythm over an extended period can provide more accurate information about these irregularities compared to the standard 24-hour monitoring currently used.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with MVP through an echocardiogram or MRI. They also need to have a moderate to severe impact on their daily activities due to heart-related symptoms. Participants will wear a device for long-term heart monitoring and will be asked to provide consent to take part in the study. This trial is important because it could help improve how doctors detect and manage heart rhythm issues in patients with MVP, potentially leading to better care and outcomes.

Gender

ALL

Eligibility criteria

  • 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

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported