Para-Prosthetic Valve Leak Closure Observatory - PVLC2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgical or percutaneous heart valve replacement..
- Who it may be relevant to
- Registry conditions: Para-prosthetic Heart. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Para-prosthetic heart valve leakage is an evolving complication 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 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.
Interventions
- Procedure surgical or percutaneous heart valve replacement.
para-prosthetic heart valve leakage after after surgical or percutaneous heart valve replacement
Primary outcome measures
- Evaluate the technical and clinical results of the closure of para-prosthetic leaks by assessing the clinical success of the procedure [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- ≥ 16 years and older
- Non-opposition of the patient or child's legal representative
- Patient referred for a percutaneous para-prosthetic leakage closure procedure
Exclusion criteria
- ≤ 16 years of age
- Refusal of the patient to participate in the observatory or the legal representative if the patient is a minor.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Marie Lannelongue Hospital — Le Plessis-Robinson
Identifiers
NCT: NCT07049991 · 2019-A02930-57