European Multicentre Registry of Percutaneous Paravalvular Leak Closure

Recruiting

• Conditions: Paravalvular Aortic Regurgitation; Quality of Life; Outcomes; Paravalvular Mitral Regurgitation; Paravalvular Leak; Cardiac Valve Disease

• Registration Number: NCT05506293
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

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.

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-03-07
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-18
• Last Update Posted: 2022-08-18
• Primary Completion: 2024-12-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

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

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