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European Multicentre Registry of Percutaneous Paravalvular Leak Closure
Sponsor: Centre Chirurgical Marie Lannelongue
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.
Official title: European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study
Key Details
Gender
All
Age Range
16 Years - 110 Years
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2020-01-01
Completion Date
2026-07-01
Last Updated
2022-08-18
Healthy Volunteers
No
Conditions
Interventions
percutaneous paravalvular leak closure
the procedure consists of deployment of an occluder or a vascular plug within the cardiac paravalvular leak. The device is inserted percutaneously from a femoral vascular approach or from a trans-apical approach. The device is deployed through a delivery sheath within the leak. Stability and efficacy to occlude the leak are assessed by transoesophageal echocardiography prior to device release. Type of devices to be inserted varied : * Amplatzer vascular plug 3 * occlutech paravalvular leak device * amplatzer vascular plug 2 * amplatzer muscular ventricular septal defect * amplatzer vascular plug 4 Devices to be implanted are under the responsability of the local investigator and are not based on the study design.
Locations (33)
CHU Charleroi
Charleroi, Belgium
Podlesi hospital
Třinec, Czechia
CHU Amiens
Amiens, France
Hopital d Annecy
Annecy, France
CHU Henri Mondor
Créteil, France
CHU Grenoble
Grenoble, France
centre chirurgical Marie Lannelongue
Le Plessis-Robinson, France
Hopital Prive Brabois
Lille, France
CHU La Timone
Marseille, France
Hopital Europeen
Marseille, France
Hopital Prive Clairval
Marseille, France
CHU Nancy
Nancy, France
Hopital prive les Franciscaines
Nîmes, France
HEGP
Paris, France
Hopital Bichat
Paris, France
Hopital Pitie Salpetriere
Paris, France
CHU Rennes
Rennes, France
Hopital Charles Nicolle
Rouen, France
Centre Cardiologique du Nord
Saint-Denis, France
institut Arnault Tzanck
Saint-Laurent-du-Var, France
CHU Toulouse
Toulouse, France
Clinique Pasteur
Toulouse, France
Medipole Lyon Villeurbanne
Villeurbanne, France
National and kapodistrian university of athens
Athens, Greece
University School of Milan
Milan, Italy
Pauls Stradins Clinical University Hospital
Riga, Latvia
Vilnius University Hospital
Vilnius, Lithuania
hospital infantil de Mexico Frederico Gomez
Mexico City, Mexico
Medical University of Silesia
Katowice, Poland
Hospital Clinic of Barcelona
Barcelona, Spain
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Royal Papworth hospital
Cambridge, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom