European Multicentre Registry of Percutaneous Paravalvular Leak Closure
NCT ID: NCT05506293
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2020-01-01
2026-07-01
Brief Summary
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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.
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Detailed Description
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SECONDARY OBJECTIVE Technical success of the procedure defined by successful placement of the prosthesis at the intended site with at least a 1 grade reduction in leakage and residual leakage grade 0-1 Change in quality of life after closure of para-prosthetic leakage at 3 months Evolution of clinical and biological markers of hemolysis and heart failure between at 3 months evolution of clinical markers of functional capacity 4. JUDGMENT CRITERIA 4.1 PRIMARY ENDPOINT
-Clinical success of the procedure:
Clinical success will be assessed on a composite endpoint at 2 years:
* vital status,
* hospitalization for heart failure,
* blood transfusion for hemolysis,
* surgical or percutaneous re-intervention on the treated valve. 4.2 SECONDARY ENDPOINTS The technical, echographic, biological and clinical data of the procedure and post procedure will be recorded as well as the complication rates. The EQ5D-5L quality of life score will be evaluated before the procedure, between 1 and 3 months, and post procedure.
STUDY POPULATION INCLUSION CRITERIA
To be included, each patient must meet all of the following conditions:
* Patients aged 16 years and older,
* Patients or the representative of the parental authority of the minor patient who does not object to participation in the observatory,
* Patients referred for a para-prosthetic leak closure procedure NON-INCLUSION CRITERIA Patients presenting at least one of the following criteria cannot be included
* Patients under 16 years of age,
* Refusal of the patient or the representative of the parental authority of the minor patient to participate in the observatory.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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paravalvular leak
patients referred for percutaneous paravalvular leak closure
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
110 Years
ALL
No
Sponsors
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Easy-CRF
UNKNOWN
Centre Chirurgical Marie Lannelongue
OTHER
Responsible Party
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Principal Investigators
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Adel Aminian
Role: primary
Jaroslav Januska
Role: primary
Laurent Leborgne
Role: primary
Lionel Mangin
Role: primary
Emmanuel Teiger
Role: primary
Helene Bouvaist
Role: primary
Regis Ketelers
Role: primary
Guillaume Bonnet
Role: primary
Sebastien Armero
Role: primary
Frederic Collet
Role: primary
Batric Popovic
Role: primary
Vlad Ciobotaru
Role: primary
Christian Spaulding
Role: primary
Eric Brochet
Role: primary
Gregory Ducrocq
Role: backup
Nadjib Hammoudi
Role: primary
Guillaume Leurent
Role: primary
Fabrice Bauer
Role: primary
Mohammed Nejjari
Role: primary
Emmanuelle Arigon
Role: primary
Frederic Bouisset
Role: primary
Nicolas Combes
Role: primary
Didier Champagnac
Role: primary
Carmen Moldovan
Role: primary
Eustaquio Onorato
Role: primary
Ainars Rudzitis
Role: primary
Aleksejus Zorinas
Role: primary
Juan Pablo Sandoval
Role: primary
Grzegorz Smolka
Role: primary
Xavier Freixa
Role: primary
Teoman Kilic
Role: primary
Patrick Calvert
Role: primary
Behan Miles
Role: primary
Other Identifiers
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2019-A02930-57
Identifier Type: -
Identifier Source: org_study_id
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