PULSTA TPV Observational Study
NCT07747207 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-08-10
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
Sponsors & Collaborators
-
Avania
collaborator INDUSTRY -
Taewoong Medical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Mario Carminati · Niguarda Hospital
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-31
- Primary Completion
- 2028-07-31
- Completion
- 2033-10-31
Countries
- Germany
- Italy
- Poland
- South Korea
- Spain
- Turkey (Türkiye)
Study Locations
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