Registry for closing leaks around heart valves

European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

Observational Centre Chirurgical Marie Lannelongue · NCT05506293

This study is testing whether a new procedure to close leaks around heart valves can improve the quality of life for patients with heart valve disease.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages16 Years to 110 Years
SexAll
SponsorCentre Chirurgical Marie Lannelongue Academic / other
Locations33 sites (Charleroi and 32 other locations)
Trial IDNCT05506293 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the clinical outcomes of transcatheter closure of para-prosthetic leaks in patients with cardiac valve disease. It focuses on assessing the technical success of the procedure, defined by a significant reduction in leakage, and the impact on patients' quality of life over a three-month period. The study will collect data on various clinical and biological markers, as well as complications associated with the procedure. The goal is to provide a comprehensive understanding of the effectiveness and safety of this intervention in high-risk patients.

Who should consider this trial

Good fit: Ideal candidates are patients aged 16 years and older who are referred for a percutaneous para-prosthetic leak closure procedure.

Not a fit: Patients under 16 years old or those who refuse to participate will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients with para-prosthetic leaks, potentially enhancing their quality of life and reducing complications.

How similar studies have performed: While there is limited literature on percutaneous leak closure, the study aims to build on existing knowledge and improve outcomes, indicating a potential for success based on advancements in technique and technology.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* ≥16 years of age No opposition from the patient or the representative of the parental authority if the patient is a minor Patient referred for a percutaneous paraprosthetic leak closure procedure

Exclusion Criteria:

* \< 16 years old Refusal of the patient to participate in the observatory or of the legal representative if the patient is a minor

Where this trial is running

Charleroi and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Cardiac Valve DiseaseParavalvular Aortic RegurgitationParavalvular Mitral RegurgitationParavalvular LeakQuality of LifeOutcomesparavalvular leakpercutaneous intervention
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.