Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2020-01-01
2027-07-01
Brief Summary
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Percutaneous closure of para-prosthetic leaks has developed as an alternative to surgery in high-risk surgical patients. These procedures remain difficult on the technical side with a significant risk of failure and complications but have been improving since the development of dedicated prostheses and the increase in operator experience.
A sharing of experience through the creation of an international expert group has been initiated since 2017 formalised by biannual expert meetings, the elaboration of recommendations in progress and the establishment of an international observatory PVLC1(CCTIRS N°16-62) on 2017-2019.
Beyond the technical aspects and the follow-up of major cardiovascular events collected in PVLC1, the investigators also wonder what impact these procedures have on the quality of life of patients. The investigators suggest that even a partial decrease in para-prosthetic leakage may be associated with an improvement in quality of life by reducing the need for transfusion and/or reducing dyspnea.
A new PVLC2 study is justified to continue the evolutionary follow-up of the technical and clinical results of these procedures, accompanied by the evaluation of the possible benefit on the quality of life of the patients.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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surgical or percutaneous heart valve replacement.
para-prosthetic heart valve leakage after after surgical or percutaneous heart valve replacement
Eligibility Criteria
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Inclusion Criteria
* Non-opposition of the patient or child's legal representative
* Patient referred for a percutaneous para-prosthetic leakage closure procedure
Exclusion Criteria
* Refusal of the patient to participate in the observatory or the legal representative if the patient is a minor.
16 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Locations
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Marie Lannelongue Hospital
Le Plessis-Robinson, , France
Countries
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Facility Contacts
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Other Identifiers
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2019-A02930-57
Identifier Type: -
Identifier Source: org_study_id
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