European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis. Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 110
Healthy Volunteers: f
View:

• ≥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

Locations
Other Locations
Belgium
CHU Charleroi
RECRUITING
Charleroi
France
CHU Amiens
RECRUITING
Amiens
Hopital d Annecy
RECRUITING
Annecy
CHU Henri Mondor
RECRUITING
Créteil
CHU Grenoble
RECRUITING
Grenoble
centre chirurgical Marie Lannelongue
RECRUITING
Le Plessis-robinson
Hopital Prive Brabois
RECRUITING
Lille
CHU La Timone
RECRUITING
Marseille
Hopital Europeen
RECRUITING
Marseille
Hopital Prive Clairval
RECRUITING
Marseille
CHU Nancy
RECRUITING
Nancy
Hopital prive les Franciscaines
RECRUITING
Nîmes
HEGP
RECRUITING
Paris
Hopital Bichat
RECRUITING
Paris
Hopital Pitie Salpetriere
RECRUITING
Paris
CHU Rennes
RECRUITING
Rennes
Hopital Charles Nicolle
RECRUITING
Rouen
Centre Cardiologique du Nord
RECRUITING
Saint-denis
institut Arnault Tzanck
RECRUITING
Saint-laurent-du-var
CHU Toulouse
RECRUITING
Toulouse
Clinique Pasteur
RECRUITING
Toulouse
Medipole Lyon Villeurbanne
RECRUITING
Villeurbanne
Greece
National and kapodistrian university of athens
RECRUITING
Athens
Italy
University School of Milan
RECRUITING
Milan
Latvia
Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Lithuania
Vilnius University Hospital
RECRUITING
Vilnius
Mexico
hospital infantil de Mexico Frederico Gomez
RECRUITING
Mexico City
Poland
Medical University of Silesia
RECRUITING
Katowice
Spain
Hospital Clinic of Barcelona
RECRUITING
Barcelona
Turkey
Kocaeli University Medical Faculty
RECRUITING
Kocaeli
United Kingdom
Royal Papworth hospital
RECRUITING
Cambridge
Edinburgh Royal Infirmary
RECRUITING
Edinburgh
Contact Information
Primary
Sebastien Hascoet, MD, PhD
s.hascoet@ghpsj.fr
0033140942429
Backup
Benoit Gerardin, MD
b.gerardin@ghpsj.fr
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 400
Treatments
paravalvular leak
patients referred for percutaneous paravalvular leak closure
Sponsors
Collaborators: Easy-CRF
Leads: Centre Chirurgical Marie Lannelongue

This content was sourced from clinicaltrials.gov