Closing leaks around prosthetic heart valves (PVLC2)
Official title: Para-Prosthetic Valve Leak Closure Observatory - PVLC2
Run by Fondation Hôpital Saint-Joseph · NCT07049991 · Data updated 2026-11-12
This observatory follows people with leaks around prosthetic heart valves who are referred for percutaneous leak closure to see if the procedure improves symptoms, complications, and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 1 site (Le Plessis-Robinson) |
| Status | Recruiting |
| Started | January 1, 2020 |
| Main results expected | January 1, 2022 |
| Study ends | July 1, 2027 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT07049991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 16 or older who have a para‑prosthetic valve leak and are referred for percutaneous closure, particularly those at higher risk for repeat surgery.
✕Probably not a fit
Patients younger than 16, those who refuse participation, or patients with leaks judged unsuitable for percutaneous closure are unlikely to benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PVLC2 is an observational registry that collects procedural details, technical outcomes, complications, and follow-up events in patients referred for percutaneous closure of para‑prosthetic valve leaks. Data collection builds on an international expert group and prior PVLC1 work, with periodic expert meetings and shared recommendations to harmonize practice. The registry captures both short‑term procedural success and longer‑term outcomes including heart failure events, hemolysis, and patient‑reported quality of life. The aim is to document real‑world performance of devices and operator approaches to inform best practices.
Why it matters
Potential benefit: If successful, the observatory could improve patient selection and techniques for percutaneous leak closure, reducing the need for repeat surgery and improving symptoms and hemolysis outcomes.
How similar studies have gone: Percutaneous closure techniques and dedicated devices have shown improving technical success in prior registries and case series, and PVLC1 collected earlier multicenter outcome data from 2017–2019.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Marie Lannelongue Hospital
Le Plessis-Robinson, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.