Clinical trial NCT05506293: European Multicentre Registry of Percutaneous Paravalvular Leak Closure
Official title: European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Valve Disease
Paravalvular Aortic Regurgitation
Paravalvular Mitral Regurgitation
Paravalvular Leak
Quality of Life
Outcomes
Keywords: paravalvular leak
percutaneous intervention
quality of life
outcomes
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
Collaborators: name: Easy-CRF
First posted: 2022-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical success
timeFrame: 1 year
Secondary outcomes:
measure: clinical success
timeFrame: 2 year
measure: quality of life
timeFrame: 30 days
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Třinec
country: Czechia
facility: Podlesi hospital
city: Amiens
country: France
facility: CHU Amiens
city: Annecy
country: France
facility: Hopital d Annecy
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble
city: Le Plessis-Robinson
country: France
facility: centre chirurgical Marie Lannelongue
city: Lille
country: France
facility: Hopital Prive Brabois
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Hopital Prive Clairval
city: Nancy
country: France
facility: CHU Nancy
city: Nîmes
country: France
facility: Hopital prive les Franciscaines
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Saint-Laurent-du-Var
country: France
facility: institut Arnault Tzanck
city: Toulouse
country: France
facility: CHU Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Villeurbanne
country: France
facility: Medipole Lyon Villeurbanne
city: Athens
country: Greece
facility: National and kapodistrian university of athens
city: Milan
country: Italy
facility: University School of Milan
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Mexico City
country: Mexico
facility: hospital infantil de Mexico Frederico Gomez
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Cambridge
country: United Kingdom
facility: Royal Papworth hospital
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
Study officials:
affiliation: s.hascoet@ghpsj.fr
name: Sebastien Hascoet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: