European Multicentre Registry of Percutaneous Paravalvular Leak Closure

Quality of Life Clinical Trial

— EuroPVL  

Official title:

European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506293
• Other study ID #: 2019-A02930-57
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: July 1, 2026

Study information

• Verified date: August 2022
• Source: Centre Chirurgical Marie Lannelongue
• Contact: Sebastien Hascoet, MD, PhD
• Phone: 0033140942429
• Email: s.hascoet[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Cardiac Valve Disease
• Heart Valve Diseases
• Mitral Valve Insufficiency
• Outcomes
• Paravalvular Aortic Regurgitation
• Paravalvular Leak
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU Charleroi	Charleroi
Czechia	Podlesi hospital	Trinec
France	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
Greece	National and kapodistrian university of athens	Athens
Italy	University School of Milan	Milan
Latvia	Pauls Stradins Clinical University Hospital	Riga
Lithuania	Vilnius University Hospital	Vilnius
Mexico	hospital infantil de Mexico Frederico Gomez	Mexico City
Poland	Medical University of Silesia	Katowice
Spain	Hospital Clinic of Barcelona	Barcelona
Turkey	Kocaeli University Medical Faculty	Kocaeli
United Kingdom	Royal Papworth hospital	Cambridge
United Kingdom	Edinburgh Royal Infirmary	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue	Easy-CRF

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Greece,  Italy,  Latvia,  Lithuania,  Mexico,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	quality of life	evolution of quality of life between baseline and 3 months after the procedure on the EQ5D-5L score	30 days