PULSTA TPV Observational Study
ConditionHeart Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorTaewoong Medical Co., Ltd.
About this trial
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
Qualifiers
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.
Disqualifiers
Patients who have not signed informed consent
Patients who are contraindicated for the implantation per the device's Instructions for Use.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 1 trial groupSponsors and collaborators
Taewoong Medical Co., Ltd.
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov