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Not Yet Recruiting NCT07747207

PULSTA TPV Observational Study

Conditions: Heart Disease

Sex: All
Ages: 10 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Taewoong Medical Co., Ltd.

Location: Deutsches Herzzentrum München Munich Bavaria

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07747207). StuddyBuddy aggregates publicly available trial information.