PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Status Active, not recruiting

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

Clinical Trial Details

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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