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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Study completion date: Mar 2025 to Mar 2030v9
  3. Re-verified, no change to tracked fieldsv8
  4. Study sites: 1 to 3v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Lead sponsor: [Redacted] to W.L.Gore & Associatesv5 Show 5 more changesShow less
    • Trial status: Withheld to Active, Not Recruiting
    • Primary completion date: Apr 13, 2020
    • Study completion date: Mar 2025
    • Start date: Jun 7, 2018
    • Study title shortened, about 1 word
  2. 3 versions Re-verified since Aug 15, 2018, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03441971
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
Related terms Heart Defects, Congenital, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov