An observational study in Cardiac Valve Disease, Paravalvular Aortic Regurgitation and Paravalvular Mitral Regurgitation, sponsored by Centre Chirurgical Marie Lannelongue. Recruiting at 33 sites in 12 countries. Open to participants aged 16 Years to 110 Years. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Centre Chirurgical Marie Lannelongue · Observational
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:
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
This study's planned enrollment of 400 is above the median of 300 across 226 observational studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Centre Chirurgical Marie Lannelongue is the lead sponsor of 40 studies on the registry; 3 are open to participants now.
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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
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Exclusion Criteria:
patients referred for percutaneous paravalvular leak closure
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.
Also known as: transcatheter paravalvular leak closure
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
Time frame: 1 year
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.
Time frame: 2 year
quality of life
evolution of quality of life between baseline and 3 months after the procedure on the EQ5D-5L score
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for Dec 2024, 59 months after the start.
Of 95 non-industry observational studies under Heart Valve Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 212. This study's planned 59 months is below that.
Counting every sponsor, half of 115 studies reached it within 67 months; a quarter within 23 and three quarters within 212.
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