EuroPVL: European Multicentre Registry of Percutaneous Paravalvular Leak Closure

Sponsor

Centre Chirurgical Marie Lannelongue (Other)

Overall Status

Recruiting

CT.gov ID

NCT05506293

Collaborator

Easy-CRF (Other)

400

Enrollment

Locations

Anticipated Duration (Months)

12.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Valve Disease Paravalvular Aortic Regurgitation Paravalvular Mitral Regurgitation Paravalvular Leak Quality of Life Outcomes	Procedure: percutaneous paravalvular leak closure

Detailed Description

OBJECTIVES OF THE STUDY MAIN OBJECTIVE To evaluate the clinical results of the transcatheter closure of para-prosthetic leaks.

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
paravalvular leak patients referred for percutaneous paravalvular leak closure	Procedure: 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 Names: transcatheter paravalvular leak closure

Arm

Intervention/Treatment

paravalvular leak

patients referred for percutaneous paravalvular leak closure

Procedure: 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 Names:

transcatheter paravalvular leak closure

Outcome Measures

Primary Outcome Measures

clinical success [1 year]
Device success is a composite criteria including all of the following conditions: No rehospitalizations or reinterventions for hemolysis No rehospitalizations or reinterventions for Heart Failure Improvement versus baseline in symptoms defined as decrease in NYHA functional class of at least one class vs. baseline

Secondary Outcome Measures

clinical success [2 year]
Clinical success will be assessed on a composite endpoint at 2 years including the following conditions: no death no hospitalization for heart failure, no blood transfusion for hemolysis, no surgical or percutaneous re-intervention on the treated valve.
quality of life [30 days]
evolution of quality of life between baseline and 3 months after the procedure on the EQ5D-5L score

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥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

Exclusion Criteria:

< 16 years old Refusal of the patient to participate in the observatory or of the legal representative if the patient is a minor

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Charleroi	Charleroi	Belgium
2	Podlesi hospital	Třinec	Czechia
3	CHU Amiens	Amiens	France
4	Hopital d Annecy	Annecy	France
5	CHU Henri Mondor	Créteil	France
6	CHU Grenoble	Grenoble	France
7	centre chirurgical Marie Lannelongue	Le Plessis-Robinson	France	92350
8	Hopital Prive Brabois	Lille	France
9	CHU La Timone	Marseille	France
10	Hopital Europeen	Marseille	France
11	Hopital Prive Clairval	Marseille	France
12	CHU Nancy	Nancy	France
13	Hopital prive les Franciscaines	Nîmes	France
14	HEGP	Paris	France
15	Hopital Bichat	Paris	France
16	Hopital Pitie Salpetriere	Paris	France
17	CHU Rennes	Rennes	France
18	Hopital Charles Nicolle	Rouen	France
19	Centre Cardiologique du Nord	Saint-Denis	France
20	institut Arnault Tzanck	Saint-Laurent-du-Var	France
21	CHU Toulouse	Toulouse	France
22	Clinique Pasteur	Toulouse	France
23	Medipole Lyon Villeurbanne	Villeurbanne	France
24	National and kapodistrian university of athens	Athens	Greece
25	University School of Milan	Milan	Italy
26	Pauls Stradins Clinical University Hospital	Riga	Latvia
27	Vilnius University Hospital	Vilnius	Lithuania
28	hospital infantil de Mexico Frederico Gomez	Mexico City	Mexico
29	Medical University of Silesia	Katowice	Poland
30	Hospital Clinic of Barcelona	Barcelona	Spain
31	Kocaeli University Medical Faculty	Kocaeli	Turkey
32	Royal Papworth hospital	Cambridge	United Kingdom
33	Edinburgh Royal Infirmary	Edinburgh	United Kingdom