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Clinical Trials in South Korea / NCT07747207
Starting soon Observational

PULSTA TPV Observational Study

NCT07747207 · tracked via the Priya Life Science South Korea tracker
Sponsor
Taewoong Medical Co., Ltd
Phase
Observational
Started
2026-10
Last updated
2026-08-10

Condition(s) studied

Heart Disease

Study summary

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

Eligibility

Sex
ALL
Min age
10 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with moderate to severe pulmonary regurgitation and/or pulmonary stenosis who undergo transcatheter pulmonary valve implantation using the PULSTA Transcatheter Pulmonary Valve(TPV). * Patients who are willing to participate in the study and who have voluntarily provided written informed consent. Exclusion Criteria: * Patients who have not signed informed consent * Patients who are contraindicated for the implantation per the device's Instructions for Use.

Primary outcome measure(s)

  • Procedural / device-related serious adverse events at 12 months — 12 months
  • Hemodynamic functional improvement at 12 months — 12 months
    Hemodynamic functional improvement is defined as the achievement of both of the following criteria: * Mild or less pulmonary regurgitation measured by echocardiography AND * Mean Right Ventricular Outflow Tract(RVOT) pressure gradient measured by echocardiography ≤35mmHg

Trial sites (9)

FacilityCityRegionStatus
Deutsches Herzzentrum München Munich Bavaria
Ospedale Niguarda (Milano) Milan Lombardy
Polish Mother's memorial hospital Lodz Łódź Voivodeship
Bucheon Sejong Hospital Bucheon-si Gyeonggi-do
Seoul National University Hospital (Seoul) Seoul South Korea
Severance Hospital (Seoul) Seoul South Korea
La Paz Hospital (Madrid) Madrid Madrid
Koc University Hospital (Istanbul) Istanbul Istanbul
Siyami Ersek Hospital (Istanbul) Istanbul Istanbul

More Taewoong Medical Co., Ltd. trials in South Korea

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07747207 on ClinicalTrials.gov ↗ ← All trials in South Korea