Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.

Clinical Trial Description

The TPV is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (RVOT) requiring treatment for severe pulmonary regurgitation and/or RVOT conduit obstruction. Consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post TPV implantation. ;

Study Design

Related Conditions & MeSH terms

Congenital Heart Defect
Heart Defects, Congenital
Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Pulmonary Valve; Insufficiency, Congenital

Clinical Trial Details

NCT number	NCT03110861
Study type	Interventional
Source	Taewoong Medical Co., Ltd.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 22, 2017
Completion date	December 2024

View Details

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