NCT03983512

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Taewoong Medical Co., Ltd. · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Diseases
• Pulmonary Valve Regurgitation
• Pulmonary Valve Stenosis
• Tetralogy of Fallot

Interventions

Type	Name	Description
DEVICE	PULSTA TPV System	PULSTA transcatheter pulmonary valve replacement.

Timeline

• Start date: 2019-10-07
• Primary completion: 2022-09-21
• Completion: 2026-12-01
• First posted: 2019-06-12
• Last updated: 2026-04-13

Locations

11 sites across 6 countries: Germany, Italy, Netherlands, South Korea, Spain, Turkey (Türkiye)