NCT05506293

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
12 countries

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 2020Jul 2026

Study Start

First participant enrolled

January 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

5 years

First QC Date

March 7, 2022

Last Update Submit

August 16, 2022

Conditions

Cardiac Valve DiseaseParavalvular Aortic RegurgitationParavalvular Mitral RegurgitationParavalvular LeakQuality of LifeOutcomes

Keywords

paravalvular leakpercutaneous interventionquality of lifeoutcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • clinical success

    2 year

  • quality of life

    30 days

Study Arms (1)

paravalvular leak

patients referred for percutaneous paravalvular leak closure

Procedure: percutaneous paravalvular leak closure

Interventions

percutaneous paravalvular leak closurePROCEDURE

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.

Also known as: transcatheter paravalvular leak closure
paravalvular leak

Eligibility Criteria

Age16 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • ≥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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

CHU Charleroi

Charleroi, Belgium

RECRUITING

Podlesi hospital

Třinec, Czechia

RECRUITING

CHU Amiens

Amiens, France

RECRUITING

Hopital d Annecy

Annecy, France

RECRUITING

CHU Henri Mondor

Créteil, France

RECRUITING

CHU Grenoble

Grenoble, France

RECRUITING

centre chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

Hopital Prive Brabois

Lille, France

RECRUITING

CHU La Timone

Marseille, France

RECRUITING

Hopital Europeen

Marseille, France

RECRUITING

Hopital Prive Clairval

Marseille, France

RECRUITING

CHU Nancy

Nancy, France

RECRUITING

Hopital prive les Franciscaines

Nîmes, France

RECRUITING

HEGP

Paris, France

RECRUITING

Hopital Bichat

Paris, France

RECRUITING

Hopital Pitie Salpetriere

Paris, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

Hopital Charles Nicolle

Rouen, France

RECRUITING

Centre Cardiologique du Nord

Saint-Denis, France

RECRUITING

institut Arnault Tzanck

Saint-Laurent-du-Var, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

Clinique Pasteur

Toulouse, France

RECRUITING

Medipole Lyon Villeurbanne

Villeurbanne, France

RECRUITING

National and kapodistrian university of athens

Athens, Greece

RECRUITING

University School of Milan

Milan, Italy

RECRUITING

Pauls Stradins Clinical University Hospital

Riga, Latvia

RECRUITING

Vilnius University Hospital

Vilnius, Lithuania

RECRUITING

hospital infantil de Mexico Frederico Gomez

Mexico City, Mexico

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Hospital Clinic of Barcelona

Barcelona, Spain

RECRUITING

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

RECRUITING

Royal Papworth hospital

Cambridge, United Kingdom

RECRUITING

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sebastien Hascoet, MD, PhD

    s.hascoet@ghpsj.fr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastien Hascoet, MD, PhD

CONTACT

0033140942429s.hascoet@ghpsj.fr

Benoit Gerardin, MD

CONTACT

b.gerardin@ghpsj.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

August 18, 2022

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)FR(21)PL(1)TU(1)GB(2)ES(1)LA(1)CZ(1)IT(1)GR(1)LI(1)BE(1)