Clinical Trial

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2019-06-10; most recent amendment 2026-04-08.
Status change: Recruiting → Active, Not Recruiting 2022-06-16
Status change: Not Yet Recruiting → Recruiting 2020-01-05
Trial Details
NCT Number NCT03983512
Lead Sponsor Taewoong Medical Co., Ltd.
Collaborators: Avania
Conditions Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
Enrollment 58 participants
Start Date 2019-10-07
Primary Completion 2022-09-21 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-13