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Showing 1-8 of 8 trials
NCT04860765
This 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.
NCT05378386
This 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
NCT02656290
The 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.
NCT02555319
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.
NCT05090228
This study investigates damage of the right cardiac chamber in adult patients with a congenital heart defect involving the pulmonary valve (the heart valve between the right cardiac chamber and the lungs). The investigators want to investigate if novel, less invasive techniques are feasible to assess damage of this right cardiac chamber, to improve follow-up and timing of intervention (valve replacement) in this group of patients.
NCT01092442
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
NCT00112320
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the burden of handling a larger than normal amount of blood flow on the RV. Over the years, that extra burden leads to enlargement of the RV and to a decrease in its function. Treatment often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the damaged pulmonary valve aims to minimize the leakage and help the RV function better. This study is designed to compare two methods of how the operation (called pulmonary valve replacement \[PVR\]) is performed. In the first method, a new valve is inserted and only the area of the old valve is operated on; this is the standard PVR. The second method involves inserting the new valve in the same way as the standard method but, in addition, areas of the right ventricular wall that are scarred and not functioning well are removed (PVR plus right ventricular remodeling). This study will evaluate which method is more effective based on the size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months following surgery, as compared to its size and function before the operation.
NCT00259207
The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract: a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation.