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NOT YET RECRUITING
NCT07747207

PULSTA TPV Observational Study

Sponsor: Taewoong Medical Co., Ltd.

View on ClinicalTrials.gov

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

Official title: An Observational Study on the Clinical Outcomes and Long-term Follow-up of the PULSTATM Transcatheter Pulmonary Valve (TPV)

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-10

Completion Date

2033-10

Last Updated

2026-08-05

Healthy Volunteers

No

Conditions

Locations (9)

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Ospedale Niguarda (Milano)

Milan, Lombardy, Italy

Polish Mother's memorial hospital

Lodz, Łódź Voivodeship, Poland

Bucheon Sejong Hospital

Bucheon-si, Gyeonggi-do, South Korea

Seoul National University Hospital (Seoul)

Seoul, South Korea

Severance Hospital (Seoul)

Seoul, South Korea

La Paz Hospital (Madrid)

Madrid, Madrid, Spain

Koc University Hospital (Istanbul)

Istanbul, Istanbul, Turkey (Türkiye)

Siyami Ersek Hospital (Istanbul)

Istanbul, Istanbul, Turkey (Türkiye)