Para-Prosthetic Valve Leak Closure Observatory - PVLC2

Launched by FONDATION HÔPITAL SAINT-JOSEPH · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a procedure to fix leaks that sometimes happen around artificial heart valves after they are surgically or minimally invasively put in. These leaks, called para-prosthetic leaks, can cause serious problems like heart failure or damage to red blood cells. The study focuses on a less invasive method to close these leaks using a small device inserted through a blood vessel, which can be an option for patients who may face higher risks with traditional surgery. The researchers want to learn more about how well this procedure works, how safe it is, and whether it helps improve patients’ quality of life by reducing symptoms like shortness of breath or the need for blood transfusions.

People who are 16 years or older and have been referred for this leak-closing procedure may be eligible to join the study, as long as they agree to participate (or their legal guardian agrees if they are minors). Participants will receive the procedure to close the leak and will be followed over time to see how they do. This study is part of an ongoing international effort to improve care for patients with these heart valve leaks by sharing expert knowledge and tracking outcomes. If you or a loved one has a leak around a replaced heart valve and is considering treatment, this trial might offer valuable information and support.

Gender

ALL

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.