MASA Valve Early Feasibility Study
Tetrology of FallotPulmonary Stenosis4 moreThe MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.
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.
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and...
Hypoplastic Left Heart SyndromeTotal Anomalous Pulmonary Venous Return8 moreThis clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, patients that participate will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. The hypotheses of this trial are: that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups. the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery
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.
Optical Tissue Identification for Myocardial Architecture
Ventricular Septal DefectComplete Atrioventricular Canal1 moreThe goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.
Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms...
Congenital Heart DiseasePulmonary Valve StenosesA prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to - evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation - evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Heart DefectsCongenital3 moreThis study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction...
Pulmonary Valve InsufficiencyPulmonary Valve Stenosis5 moreThis study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
Pulmonary Artery Repair With Covered Stents
Pulmonary StenosisPulmonary Regurgitation1 moreThe Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the right ventricle of the heart to the pulmonary arteries. Patients undergoing replacement of their pulmonary valve by transcatheter technique Melody Valve) are at risk of developing such tears in the process of preparing the conduit to accept the new valve. In order to implant such a valve, the connection between the right ventricle and the pulmonary arteries often needs to be enlarged. High pressure balloons may be needed and these balloons can sometimes cause tears in or even rupture of the connecting conduit. Such tears can allow blood to flow into the chest and rarely this can lead to a life-threatening emergency. Experience suggests that such tears can be closed by implanting into the conduit a metallic stent with an outer covering, rebuilding the wall and allowing continuation of the valve implant.
A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary...
Congenital Heart DefectsCardiovascular Abnormalities2 moreThe 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.