Actively Recruiting
European Multicentre Registry of Percutaneous Paravalvular Leak Closure
Led by Centre Chirurgical Marie Lannelongue · Updated on 2022-08-18
400
Participants Needed
33
Research Sites
339 weeks
Total Duration
On this page
Sponsors
C
Centre Chirurgical Marie Lannelongue
Lead Sponsor
E
Easy-CRF
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
European Multicentre Registry of Percutaneous Paravalvular Leak Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 16 years of age or older
- No objection from the patient or legal guardian if the patient is a minor
- Patient referred for a percutaneous paravalvular leak closure procedure
You will not qualify if you...
- Under 16 years of age
- Patient or legal guardian refuses participation in the registry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
CHU Charleroi
Charleroi, Belgium
Actively Recruiting
2
Podlesi hospital
Třinec, Czechia
Actively Recruiting
3
CHU Amiens
Amiens, France
Actively Recruiting
4
Hopital d Annecy
Annecy, France
Actively Recruiting
5
CHU Henri Mondor
Créteil, France
Actively Recruiting
6
CHU Grenoble
Grenoble, France
Actively Recruiting
7
centre chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350
Actively Recruiting
8
Hopital Prive Brabois
Lille, France
Actively Recruiting
9
CHU La Timone
Marseille, France
Actively Recruiting
10
Hopital Europeen
Marseille, France
Actively Recruiting
11
Hopital Prive Clairval
Marseille, France
Actively Recruiting
12
CHU Nancy
Nancy, France
Actively Recruiting
13
Hopital prive les Franciscaines
Nîmes, France
Actively Recruiting
14
HEGP
Paris, France
Actively Recruiting
15
Hopital Bichat
Paris, France
Actively Recruiting
16
Hopital Pitie Salpetriere
Paris, France
Actively Recruiting
17
CHU Rennes
Rennes, France
Actively Recruiting
18
Hopital Charles Nicolle
Rouen, France
Actively Recruiting
19
Centre Cardiologique du Nord
Saint-Denis, France
Actively Recruiting
20
institut Arnault Tzanck
Saint-Laurent-du-Var, France
Actively Recruiting
21
CHU Toulouse
Toulouse, France
Actively Recruiting
22
Clinique Pasteur
Toulouse, France
Actively Recruiting
23
Medipole Lyon Villeurbanne
Villeurbanne, France
Actively Recruiting
24
National and kapodistrian university of athens
Athens, Greece
Actively Recruiting
25
University School of Milan
Milan, Italy
Actively Recruiting
26
Pauls Stradins Clinical University Hospital
Riga, Latvia
Actively Recruiting
27
Vilnius University Hospital
Vilnius, Lithuania
Actively Recruiting
28
hospital infantil de Mexico Frederico Gomez
Mexico City, Mexico
Actively Recruiting
29
Medical University of Silesia
Katowice, Poland
Actively Recruiting
30
Hospital Clinic of Barcelona
Barcelona, Spain
Actively Recruiting
31
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Actively Recruiting
32
Royal Papworth hospital
Cambridge, United Kingdom
Actively Recruiting
33
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Actively Recruiting
Research Team
S
Sebastien Hascoet, MD, PhD
CONTACT
B
Benoit Gerardin, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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