NCT03110861

Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study

A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Implantation of 'Transcatheter Pulmonary Valve (TPV)' for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Taewoong Medical Co., Ltd. · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement	Pulsta® Transcatheter Pulmonary Valve Replacement

Timeline

• Start date: 2017-03-22
• Primary completion: 2019-11-06
• Completion: 2024-07-12
• First posted: 2017-04-12
• Last updated: 2025-09-04

Locations

5 sites across 1 country: South Korea