Clinical Trials Logo
  1. Home
  2. Pulmonary Valve Insufficiency
  3. NCT02555319

A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Congenital Heart Defects Clinical Trial

Official title:
A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Implantation of Transcatheter Pulmonary Valve (TPV) for the Treatment of Congenital Heart Disease With Pulmonary Valve Disease

Clinical Trial Summary

The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.

Clinical Trial Description

Diverse congenital heart diseases involving the pulmonary artery, such as Tetralogy of Fallot (TOF) with or without pulmonary atresia, or transposition of the great arteries with pulmonary stenosis, require implantation of an artificial conduit between the right ventricle and the pulmonary artery(PA). Because these conduits finally degenerate and result in pulmonary regurgitation and/or stenosis and progressive right ventricle (RV) dilation and eventual failure, patients need repetitive surgery for conduit revision. Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to surgery in patients with dysfunctional right ventricular outflow tract (RVOT). TPV is a large-diameter (up to 28 mm) self-expandable stent with a relatively low profile from a nitinol wire backbone with valve leaflets made from porcine pericardial tissue. 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 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

Clinical Trial Details
NCT number NCT02555319
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase N/A
Start date August 26, 2015
Completion date October 25, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT01671566 - Interval Training in Adults With Congenital Heart Disease a Randomized Trial N/A
Recruiting NCT01421030 - Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques Phase 0
Withdrawn NCT00981591 - Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients Phase 1/Phase 2
Completed NCT01567579 - An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
Terminated NCT00208676 - Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease N/A
Completed NCT01941576 - Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot N/A
Completed NCT01475357 - Intestinal Function in Neonates With Complex Congenital Heart Disease N/A
Active, not recruiting NCT01227096 - Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery N/A
Completed NCT01201486 - Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester N/A
Completed NCT00397514 - Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery N/A
Completed NCT02232399 - Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease? Phase 2
Completed NCT05191654 - Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD
Recruiting NCT06267859 - Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children Early Phase 1
Completed NCT02320669 - Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass Phase 3
Completed NCT01489475 - Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass N/A
Withdrawn NCT00579358 - Molecular Basis of Congenital Heart Defects
Recruiting NCT01196182 - Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
Recruiting NCT04382573 - Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.
Recruiting NCT03822442 - MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
Completed NCT00450684 - Cardiac Resynchronization Therapy in Congenital Heart Defects Phase 2/Phase 3