Clinical Trials Logo
  1. Home
  2. Pulmonary Regurgitation
  3. NCT04084132

Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation

Tetralogy of Fallot Clinical Trial

Official title:
Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation - Combined Cross-sectional and Prospective, Multi-centre, Randomized, Parallel-group Clinical Trial

Clinical Trial Summary

Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year. Corrective surgery is usually performed within the first year. In 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. This however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. To avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. Most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. The current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with ToF will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of ToF, as well as suggestions about the optimal timing for re-valving. Among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04084132
Study type Interventional
Source Rigshospitalet, Denmark
Contact Mathis Gröning, MD, DMSc
Phone +45 42404489
Email mathis.groening@regionh.dk
Status Recruiting
Phase N/A
Start date April 1, 2019
Completion date December 31, 2031
View Details
See also
  Status Clinical Trial Phase
Completed NCT02534792 - Early Revalvulation After Fallot Repair Improves Clinical Outcome N/A
Completed NCT00536432 - Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot N/A
Not yet recruiting NCT05485545 - Asynchrony in Operated Tetralogy of Fallot N/A
Completed NCT01941576 - Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot N/A
Active, not recruiting NCT03983512 - PULSTA Transcatheter Pulmonary Valve Pre-Approval Study N/A
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Completed NCT01762124 - Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV) N/A
Active, not recruiting NCT02161471 - Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance
Not yet recruiting NCT05916976 - Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment N/A
Recruiting NCT04106479 - NIRS in Congenital Heart Defects - Correlation With Echocardiography
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Recruiting NCT05236153 - Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot N/A
Recruiting NCT03049995 - Stress Echo 2020 - The International Stress Echo Study
Completed NCT02586740 - Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation N/A
Terminated NCT00564993 - Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot Phase 3
Recruiting NCT05122962 - Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Completed NCT06097377 - Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
Completed NCT03835494 - Analysis of RV-Dysfunction in Fallot Patients N/A
Not yet recruiting NCT03275844 - Physical Capacity and Activity in Children With Congenital Heart Disease N/A
Recruiting NCT02590679 - Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p Phase 2/Phase 3