Actively Recruiting

Age: 16Years - 110Years
All Genders
NCT05506293

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

Age: 16Years - 110Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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