Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation
Tetralogy of FallotPulmonary RegurgitationTetralogy 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.
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary...
Complex Congenital Heart DefectDysfunctional RVOT Conduit2 moreThis study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
Harmony TPV Post-Approval Study
Congenital Heart DiseaseTetrology of Fallot2 moreThe purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts...
Pulmonary RegurgitationA prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
Heart DiseasesPulmonary Valve Regurgitation2 moreThe 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.
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
Congenital Heart DiseaseTetrology of Fallot2 moreThe purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system.
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
Congenital Heart DefectPulmonary Valve; Insufficiency2 moreThe purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary DiseaseTranscatheter Pulmonary Valve Replacement (TPVR)3 moreTo demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart...
Pulmonary Valve InsufficiencyAim of this study is to investigate the clinical safety of a novel pediatric heart valve.
VenusP-Valve Pivotal Study (PROTEUS STUDY)
Pulmonary RegurgitationA prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.