European Multicentre Registry of Percutaneous Paravalvular Leak Closure (EuroPVL)

European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Cardiac Valve Disease; Outcomes; Paravalvular Aortic Regurgitation; Paravalvular Mitral Regurgitation; Paravalvular Leak
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Sebastien Hascoet, MD, PhD; Phone Number: 0033140942429; Email: s.hascoet@ghpsj.fr
• Study Contact Backup: Name: Benoit Gerardin, MD; Email: b.gerardin@ghpsj.fr

Study Locations

• Belgium
  • Charleroi, Belgium
    • Recruiting
    • Chu Charleroi
    • Contact: Adel Aminian
• Czechia
  • Třinec, Czechia
    • Recruiting
    • Podlesi hospital
    • Contact: Jaroslav Januska
• France
  • Amiens, France
    • Recruiting
    • CHU Amiens
    • Contact: Laurent Leborgne
  • Annecy, France
    • Recruiting
    • Hopital d Annecy
    • Contact: Lionel MANGIN
  • Créteil, France
    • Recruiting
    • CHU Henri Mondor
    • Contact: EMMANUEL TEIGER
  • Grenoble, France
    • Recruiting
    • CHU Grenoble
    • Contact: Helene Bouvaist
  • Le Plessis-Robinson, France, 92350
    • Recruiting
    • Centre Chirurgical Marie Lannelongue
    • Contact: HASCOET SEBASTIEN, PI; Phone Number: +33140942429; Email: s.hascoet@hml.fr
  • Lille, France
    • Recruiting
    • Hopital Prive Brabois
    • Contact: Regis Ketelers
  • Marseille, France
    • Recruiting
    • CHU La Timone
    • Contact: Guillaume Bonnet
  • Marseille, France
    • Recruiting
    • Hôpital Européen
    • Contact: Sebastien Armero
  • Marseille, France
    • Recruiting
    • Hôpital privé Clairval
    • Contact: Frederic Collet
  • Nancy, France
    • Recruiting
    • Chu Nancy
    • Contact: Batric Popovic
  • Nîmes, France
    • Recruiting
    • Hôpital Privé Les Franciscaines
    • Contact: Vlad Ciobotaru
  • Paris, France
    • Recruiting
    • HEGP
    • Contact: Christian Spaulding
  • Paris, France
    • Recruiting
    • Hopital Bichat
    • Contact: Eric Brochet
    • Contact: Gregory Ducrocq
  • Paris, France
    • Recruiting
    • Hopital Pitie Salpetriere
    • Contact: Nadjib Hammoudi
  • Rennes, France
    • Recruiting
    • CHU Rennes
    • Contact: GUILLAUME LEURENT
  • Rouen, France
    • Recruiting
    • Hopital Charles Nicolle
  • Saint-Denis, France
    • Recruiting
    • Centre Cardiologique du Nord
    • Contact: MOHAMMED NEJJARI
  • Saint-Laurent-du-Var, France
    • Recruiting
    • Institut Arnault Tzanck
    • Contact: Emmanuelle Arigon
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Frederic Bouisset
  • Toulouse, France
    • Recruiting
    • Clinique PASTEUR
  • Villeurbanne, France
    • Recruiting
    • Médipôle Lyon Villeurbanne
    • Contact: DIDIER CHAMPAGNAC
• Greece
  • Athens, Greece
    • Recruiting
    • National and Kapodistrian University of Athens
    • Contact: Carmen Moldovan
• Italy
  • Milan, Italy
    • Recruiting
    • University School of Milan
    • Contact: Eustaquio Onorato
• Latvia
  • Riga, Latvia
    • Recruiting
    • Pauls Stradins Clinical University Hospital
    • Contact: Ainars Rudzitis
• Lithuania
  • Vilnius, Lithuania
    • Recruiting
    • Vilnius University Hospital
    • Contact: Aleksejus Zorinas
• Mexico
  • Mexico City, Mexico
    • Recruiting
    • hospital infantil de Mexico Frederico Gomez
    • Contact: Juan Pablo Sandoval
• Poland
  • Katowice, Poland
    • Recruiting
    • Medical University of Silesia
    • Contact: Grzegorz Smolka
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic of Barcelona
    • Contact: Xavier Freixa
• Turkey
  • Kocaeli, Turkey
    • Recruiting
    • Kocaeli University Medical Faculty
    • Contact: Teoman Kilic
• United Kingdom
  • Cambridge, United Kingdom
    • Recruiting
    • Royal Papworth Hospital
    • Contact: Patrick Calvert
  • Edinburgh, United Kingdom
    • Recruiting
    • Edinburgh Royal Infirmary
    • Contact: Behan Miles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 110 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Included patients are included as part of their routine clinical care. The percutaneous intervention is not indicated for the purpose of the study but according to each centre policy after a medico-surgical meeting.

Prior to percutaneous intervention, a large investigation of functional status, quality of life, biological exam and echocardiography is performed. This investigation is done again at 1 and 2 years

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical success	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical success	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.	2 year
quality of life	evolution of quality of life between baseline and 3 months after the procedure on the EQ5D-5L score	30 days

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue
• Collaborators: Easy-CRF
• Investigators: Principal Investigator: Sebastien Hascoet, MD, PhD, s.hascoet@ghpsj.fr

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; outcomes; paravalvular leak; percutaneous intervention
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Mitral Valve Insufficiency; Aortic Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: 2019-A02930-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes