Active, not recruitingNCT03441971
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
AI Description
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).
- Who can join
- child, adult, older adult
- Participants
- 15
- Expected completion
- 2030-03
- Funded by
- industry
Conditions studied
Heart Defects, Congenital, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot
What is being tested
- DEVICE: GORE PV1
What it measures
- Valve-related mortality and device-related re-intervention, The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure, 6 months
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-02-05
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.