Clinical Trials Logo

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


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

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 NCT04580095 - Artificial Intelligence for Improved Echocardiography N/A
Completed NCT04562636 - Evaluating a Messaging Campaign in the United States 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Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A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 NCT01944254 - The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients N/A
Completed NCT01909349 - Web-based Aftercare Intervention for Cardiac Patients N/A
Recruiting NCT01457586 - Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery Phase 4
Recruiting NCT01207167 - Mediators of Atherosclerosis in South Asians Living in America
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Completed NCT02645786 - Thyrotropin Over-suppression and Heart N/A