← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07747207). StuddyBuddy aggregates publicly available trial information.