Clinical Trial

Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2018-02-15; most recent amendment 2026-02-03.
Status change: Withheld → Active, Not Recruiting 2021-06-02
Trial Details
NCT Number NCT03441971
Lead Sponsor W.L.Gore & Associates
Conditions Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
Enrollment 15 participants
Start Date 2018-06-07
Primary Completion 2020-04-13 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-05