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).
Berlin Registry of Right Heart Interventions
Tricuspid RegurgitationPulmonary RegurgitationThe present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.
ALTERRA Post-Approval Study
Pulmonary Valve InsufficiencyComplex Congenital Heart Defect3 moreThis study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement...
Congenital Heart DiseaseFallot Tetralogy2 moreSevere pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing. Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch. While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis. At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking. The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.
COMPASSION S3 Post-Approval Study
Complex Congenital Heart DefectDysfunctional RVOT Conduit3 moreThis study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
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.
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A)...
Pulmonary Valve InsufficiencyPulmonary Valve Degeneration1 moreThe objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
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.
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal...
Pulmonary Valve InsufficiencyPulmonary Regurgitation3 moreTo assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.