Registry for closing leaks around heart valves
European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study
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 type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 16 Years to 110 Years |
| Sex | All |
| Sponsor | Centre Chirurgical Marie Lannelongue Academic / other |
| Locations | 33 sites (Charleroi and 32 other locations) |
| Trial ID | NCT05506293 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
- CHU Charleroi — Charleroi, Belgium (Recruiting)
- Podlesi hospital — Třinec, Czechia (Recruiting)
- CHU Amiens — Amiens, France (Recruiting)
- Hopital d Annecy — Annecy, France (Recruiting)
- CHU Henri Mondor — Créteil, France (Recruiting)
- CHU Grenoble — Grenoble, France (Recruiting)
- centre chirurgical Marie Lannelongue — Le Plessis-Robinson, France (Recruiting)
- Hopital Prive Brabois — Lille, France (Recruiting)
- CHU La Timone — Marseille, France (Recruiting)
- Hopital Europeen — Marseille, France (Recruiting)
- Hopital Prive Clairval — Marseille, France (Recruiting)
- CHU Nancy — Nancy, France (Recruiting)
- Hopital prive les Franciscaines — Nîmes, France (Recruiting)
- Hegp — Paris, France (Recruiting)
- Hopital Bichat — Paris, France (Recruiting)
- Hopital Pitie Salpetriere — Paris, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- Hopital Charles Nicolle — Rouen, France (Recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
- institut Arnault Tzanck — Saint-Laurent-du-Var, France (Recruiting)
- CHU Toulouse — Toulouse, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- Medipole Lyon Villeurbanne — Villeurbanne, France (Recruiting)
- National and kapodistrian university of athens — Athens, Greece (Recruiting)
- University School of Milan — Milan, Italy (Recruiting)
- Pauls Stradins Clinical University Hospital — Riga, Latvia (Recruiting)
- Vilnius University Hospital — Vilnius, Lithuania (Recruiting)
- hospital infantil de Mexico Frederico Gomez — Mexico City, Mexico (Recruiting)
- Medical University of Silesia — Katowice, Poland (Recruiting)
- Hospital Clinic of Barcelona — Barcelona, Spain (Recruiting)
- Kocaeli University Medical Faculty — Kocaeli, Turkey (Türkiye) (Recruiting)
- Royal Papworth hospital — Cambridge, United Kingdom (Recruiting)
- Edinburgh Royal Infirmary — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sebastien Hascoet, MD, PhD — s.hascoet@ghpsj.fr
- Study coordinator: Sebastien Hascoet, MD, PhD
- Email: s.hascoet@ghpsj.fr
- Phone: 0033140942429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.