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| Name | Class |
|---|---|
| Easy-CRF | UNKNOWN |
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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.
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:
STUDY POPULATION INCLUSION CRITERIA
To be included, each patient must meet all of the following conditions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paravalvular leak | patients referred for percutaneous paravalvular leak closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous paravalvular leak closure | Procedure | 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 :
Devices to be implanted are under the responsability of the local investigator and are not based on the study design. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical success | Clinical success will be assessed on a composite endpoint at 2 years including the following conditions:
| 2 year |
| quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastien Hascoet, MD, PhD | Contact | 0033140942429 | s.hascoet@ghpsj.fr | |
| Benoit Gerardin, MD | Contact | b.gerardin@ghpsj.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sebastien Hascoet, MD, PhD | s.hascoet@ghpsj.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Charleroi | Recruiting | Charleroi | Belgium |
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evolution of quality of life between baseline and 3 months after the procedure on the EQ5D-5L score |
| 30 days |
| Podlesi hospital | Recruiting | Třinec | Czechia |
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| CHU Amiens | Recruiting | Amiens | France |
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| Hopital d Annecy | Recruiting | Annecy | France |
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| CHU Henri Mondor | Recruiting | Créteil | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| centre chirurgical Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
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| Hopital Prive Brabois | Recruiting | Lille | France |
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| CHU La Timone | Recruiting | Marseille | France |
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| Hopital Europeen | Recruiting | Marseille | France |
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| Hopital Prive Clairval | Recruiting | Marseille | France |
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| CHU Nancy | Recruiting | Nancy | France |
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| Hopital prive les Franciscaines | Recruiting | Nîmes | France |
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| HEGP | Recruiting | Paris | France |
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| Hopital Bichat | Recruiting | Paris | France |
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| Hopital Pitie Salpetriere | Recruiting | Paris | France |
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| CHU Rennes | Recruiting | Rennes | France |
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| Hopital Charles Nicolle | Recruiting | Rouen | France |
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| Centre Cardiologique du Nord | Recruiting | Saint-Denis | France |
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| institut Arnault Tzanck | Recruiting | Saint-Laurent-du-Var | France |
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| CHU Toulouse | Recruiting | Toulouse | France |
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| Clinique Pasteur | Recruiting | Toulouse | France |
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| Medipole Lyon Villeurbanne | Recruiting | Villeurbanne | France |
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| National and kapodistrian university of athens | Recruiting | Athens | Greece |
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| University School of Milan | Recruiting | Milan | Italy |
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| Pauls Stradins Clinical University Hospital | Recruiting | Riga | Latvia |
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| Vilnius University Hospital | Recruiting | Vilnius | Lithuania |
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| hospital infantil de Mexico Frederico Gomez | Recruiting | Mexico City | Mexico |
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| Medical University of Silesia | Recruiting | Katowice | Poland |
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| Hospital Clinic of Barcelona | Recruiting | Barcelona | Spain |
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| Kocaeli University Medical Faculty | Recruiting | Kocaeli | Turkey (Türkiye) |
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| Royal Papworth hospital | Recruiting | Cambridge | United Kingdom |
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| Edinburgh Royal Infirmary | Recruiting | Edinburgh | United Kingdom |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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