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Clinical Trial Summary

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.


Clinical Trial Description

The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03983512
Study type Interventional
Source Taewoong Medical Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date October 7, 2019
Completion date August 2026

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