PULSTA TPV Observational Study | NCT07747207

NCT07747207

Overview

NCT ID: NCT07747207
Lead Sponsor: Taewoong Medical Co., Ltd.INDUSTRY
Official Title: An Observational Study on the Clinical Outcomes and Long-term Follow-up of the PULSTATM Transcatheter Pulmonary Valve (TPV)
Brief 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
Conditions: Heart Disease
Interventions: No data available

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients with moderate to severe pulmonary regurgitation and/or pulmonary stenosis who undergo transcatheter pulmonary valve implantation using the PULSTA 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.

Locations

Deutsches Herzzentrum München

Munich, Bavaria 80636, Germany

Ospedale Niguarda (Milano)

Milan, Lombardy 20162, Italy

Polish Mother's memorial hospital

Lodz, Łódź Voivodeship 93-338, Poland

Bucheon Sejong Hospital

Bucheon-si, Gyeonggi-do 14754, South Korea

Seoul National University Hospital (Seoul)

Seoul, 3080, South Korea

Severance Hospital (Seoul)

Seoul, 3722, South Korea

La Paz Hospital (Madrid)

Madrid, Madrid 28046, Spain

Koc University Hospital (Istanbul)

Istanbul, Istanbul 34010, Turkey (Türkiye)

Siyami Ersek Hospital (Istanbul)

Istanbul, Istanbul 34668, Turkey (Türkiye)

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