Para-Prosthetic Valve Leak Closure Observatory - PVLC2

Recruiting now

Conditions studied: Para-prosthetic Heart

In brief

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.

Key facts

Study ID

NCT07049991

Run by

Fondation Hôpital Saint-Joseph

People needed

300

Starts

2020-01-01

Expected to finish

2027-07-01

Last updated by the study team

2025-07-03

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 16 years and older
• Non-opposition of the patient or child's legal representative
• Patient referred for a percutaneous para-prosthetic leakage closure procedure

You may not qualify if…

• ≤ 16 years of age
• Refusal of the patient to participate in the observatory or the legal representative if the patient is a minor.

Where it is running

• Marie Lannelongue Hospital — Le Plessis-Robinson, France (enrolling)

Full record on ClinicalTrials.gov

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