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PULSTA TPV Observational Study

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoints: details revised at 1 of 9 entries
    • Eligibility criteria expanded, about 2 words
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
Trial Details
NCT Number NCT07747207
Lead Sponsor Taewoong Medical Co., Ltd.
Collaborators: Avania
Conditions
(from sponsor)		 Heart Disease
Related terms Heart Diseases, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov