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PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Site details revised at 1 of 11 sitesv19
  2. 2 versions Re-verified since Jul 28, 2025, no change to tracked fieldsv17-v18
  3. Primary completion date: Jul 28, 2022 to Sep 21, 2022
    • Study completion date: Aug 2026 to Dec 2026
    • Site details revised at 4 of 11 sites
    v16
  4. Re-verified, no change to tracked fieldsv15
  5. Collaborator revisedv14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites revised (11)v13
  2. 2 versions Re-verified since Oct 18, 2022, no change to tracked fieldsv11-v12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 2022 to Jul 28, 2022
    • Site details revised at 11 of 11 sites
    v10
  4. Site details revised at 8 of 11 sitesv9
  5. Primary completion date: Aug 2021 to Jun 2022
    • Site details revised at 1 of 11 sites
    v8
  6. Study completion date: Aug 2025 to Aug 2026
    • Site details revised at 1 of 11 sites
    v7
  7. Primary completion date: Aug 2020 to Aug 2021
    • Site details revised at 4 of 11 sites
    v6
  8. Re-verified, no change to tracked fieldsv5
  9. Site details revised at 4 of 11 sitesv4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2019 to Oct 7, 2019
    • Site details revised at 11 of 11 sites
    v3
  11. Start date: Jul 2019 to Oct 2019v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.
Trial Details
NCT Number NCT03983512
Lead Sponsor Taewoong Medical Co., Ltd.
Collaborators: Avania
Conditions
(from sponsor)		 Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
Related terms Heart Diseases, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov