Cardiac Valve DiseaseEuroPVLNCT05506293
European Multicentre Registry of Percutaneous Paravalvular Leak Closure
An observational study of Cardiac Valve Disease and Paravalvular Aortic Regurgitation, run by Centre Chirurgical Marie Lannelongue at 33 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 16 to 110 years
- Conditions the study is for
- Cardiac Valve Disease, Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation
- What is being tested?
- percutaneous paravalvular leak closure
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 33 sitesin 12 countries
- Study dates
- 1 Jan 2020to 1 Jul 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- ≥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
Who cannot join
- < 16 years old Refusal of the patient to participate in the observatory or of the legal representative if the patient is a minor
Trial locations and contacts
33 sites in 12 countries.
Benoit Gerardin, MD contact
33 sites in 12 countries
France21 sites, 21 recruiting
- Recruiting
CHU Amiens
Amiens
Laurent Leborgne
- Recruiting
Hopital d Annecy
Annecy
Lionel Mangin
- Recruiting
CHU Henri Mondor
Créteil
Emmanuel Teiger
- Recruiting
CHU Grenoble
Grenoble
Helene Bouvaist
- Recruiting
centre chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
HASCOET SEBASTIEN, PI, +33140942429, s.hascoet@hml.fr
- Recruiting
Hopital Prive Brabois
Lille
Regis Ketelers
- Recruiting
CHU La Timone
Marseille
Guillaume Bonnet
- Recruiting
Hopital Europeen
Marseille
Sebastien Armero
- Recruiting
Hopital Prive Clairval
Marseille
Frederic Collet
- Recruiting
CHU Nancy
Nancy
Batric Popovic
- Recruiting
Hopital prive les Franciscaines
Nîmes
Vlad Ciobotaru
- Recruiting
HEGP
Paris
Christian Spaulding
- Recruiting
Hopital Bichat
Paris
Eric Brochet
Gregory Ducrocq
- Recruiting
Hopital Pitie Salpetriere
Paris
Nadjib Hammoudi
- Recruiting
CHU Rennes
Rennes
Guillaume Leurent
- Recruiting
Hopital Charles Nicolle
Rouen
Fabrice Bauer
- Recruiting
Centre Cardiologique du Nord
Saint-Denis
Mohammed Nejjari
- Recruiting
institut Arnault Tzanck
Saint-Laurent-du-Var
Emmanuelle Arigon
- Recruiting
CHU Toulouse
Toulouse
Frederic Bouisset
- Recruiting
Clinique Pasteur
Toulouse
Nicolas Combes
- Recruiting
Medipole Lyon Villeurbanne
Villeurbanne
Didier Champagnac
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Papworth hospital
Cambridge
Patrick Calvert
- Recruiting
Edinburgh Royal Infirmary
Edinburgh
Behan Miles
Greece1 site, 1 recruiting
- Recruiting
National and kapodistrian university of athens
Athens
Carmen Moldovan
Italy1 site, 1 recruiting
- Recruiting
University School of Milan
Milan
Eustaquio Onorato
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University Hospital
Riga
Ainars Rudzitis
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital
Vilnius
Aleksejus Zorinas
Mexico1 site, 1 recruiting
- Recruiting
hospital infantil de Mexico Frederico Gomez
Mexico City
Juan Pablo Sandoval
Poland1 site, 1 recruiting
- Recruiting
Medical University of Silesia
Katowice
Grzegorz Smolka
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic of Barcelona
Barcelona
Xavier Freixa
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University Medical Faculty
Kocaeli
Teoman Kilic
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Valve Disease, Paravalvular Aortic Regurgitation, Paravalvular Mitral Regurgitation, Paravalvular Leak, Quality of Life, Outcomes
- Being tested
- percutaneous paravalvular leak closure
- Keywords
- paravalvular leak, percutaneous intervention, quality of life, outcomes
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous paravalvular leak closureProcedure or surgery
Also called transcatheter 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.
| Study group | Role | What they receive |
|---|---|---|
| paravalvular leak | patients referred for percutaneous paravalvular leak closure Receives: Procedure: percutaneous paravalvular leak closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 2 year
quality of life
evolution of quality of life between baseline and 3 months after the procedure on the EQ5D-5L score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Collaborators
- Easy-CRF
- Responsible party
- Sponsor
- Investigators
- Sebastien Hascoet, MD, PhD, Principal investigator, s.hascoet@ghpsj.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506293
- Sponsor's protocol ID
- 2019-A02930-57
- Acronym
- EuroPVL
- Status last verified
- Aug 2022
- First submitted
- 7 Mar 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study
- ClinicalTrials.gov ID
- NCT05506293
- Acronym / sponsor ID
- EuroPVL / 2019-A02930-57
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Collaborators
- Easy-CRF
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paravalvular leak | – | Procedure: percutaneous paravalvular leak closurepatients referred for percutaneous paravalvular leak closure |
Who may qualify
- Ages
- 16 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- ≥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
Key exclusion criteria (1 listed)
- < 16 years old Refusal of the patient to participate in the observatory or of the legal representative if the patient is a minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous paravalvular leak closureAlso: transcatheter paravalvular leak closurethe 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. | Procedure or surgery | paravalvular leak |
Primary outcome
clinical success
Time frame: 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
2 secondary outcomes
clinical success
Time frame: 2 year
quality of life
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Gerardin, MD contact
Sebastien Hascoet, MD, PhD principal investigator
s.hascoet@ghpsj.fr
33 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Valve Disease and Paravalvular Aortic Regurgitation, run by Centre Chirurgical Marie Lannelongue at 33 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France, United Kingdom, Belgium, Czechia, Greece and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastien Hascoet, MD, PhD (0033140942429, s.hascoet@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical success (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.