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PULSTA TPV Observational Study

Not Yet RecruitingN/A

Sponsor: Taewoong Medical Co., Ltd.

Conditions: Heart Disease

Countries: Germany, Italy, Poland, South Korea, Spain, Turkey (Türkiye)

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 overview

Sex: ALL

Age: 10 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (9)

Munich, Bavaria, Germany
Milan, Lombardy, Italy
Lodz, Łódź Voivodeship, Poland
Bucheon-si, Gyeonggi-do, South Korea
Seoul, South Korea
Seoul, South Korea
Madrid, Madrid, Spain
Istanbul, Istanbul, Turkey (Türkiye)
Istanbul, Istanbul, Turkey (Türkiye)