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
Sex
ALL
Min age
10 Years
Max age
—
Healthy volunteers
No
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.
Hemodynamic functional improvement at 12 months — 12 months Hemodynamic functional improvement is defined as the achievement of both of the following criteria:
* Mild or less pulmonary regurgitation measured by echocardiography AND
* Mean Right Ventricular Outflow Tract(RVOT) pressure gradient measured by echocardiography ≤35mmHg
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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