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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04624412` - Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2	N/A
Completed	`NCT05563701` - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting	`NCT04561908` - Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access	N/A
Active, not recruiting	`NCT06190743` - Perception of Cardiovascular Risk
Completed	`NCT04562636` - Evaluating a Messaging Campaign in the United States	N/A
Completed	`NCT04580095` - Artificial Intelligence for Improved Echocardiography	N/A
Recruiting	`NCT03277365` - MyGeneRank: A Digital Platform for Next-Generation Genetic Studies	N/A
Active, not recruiting	`NCT05553106` - Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Completed	`NCT03429920` - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors	N/A
Recruiting	`NCT04390672` - Multivessel TALENT	N/A
Enrolling by invitation	`NCT03314818` - Natural History of Carotid Plaque as Determined by 3D Ultrasound	N/A
Withdrawn	`NCT03289104` - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX	N/A
Completed	`NCT02917213` - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed	`NCT02046902` - Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Completed	`NCT01909349` - Web-based Aftercare Intervention for Cardiac Patients	N/A
Completed	`NCT01944254` - The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients	N/A
Recruiting	`NCT01457586` - Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery	Phase 4
Recruiting	`NCT01541163` - Heart and Ischemic STrOke Relationship studY	N/A
Recruiting	`NCT01207167` - Mediators of Atherosclerosis in South Asians Living in America
Terminated	`NCT00968383` - Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment	N/A