COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% 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.
- Complex Congenital Heart Defect
- Dysfunctional RVOT Conduits or Previously Implanted Valve in the Pulmonic Position
- Eligible Ages
- All ages
- Eligible Genders
- Accepts Healthy Volunteers
- Weight ≥ 20 kg (44 lbs.)
- Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
- The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
- History of or active endocarditis (active treatment with antibiotics) within the past 180 days
- Leukopenia (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (Platelets < 50,000 cells/µL) or any known blood clotting disorder
- Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|Transcatheter Pulmonary Valve Implantation with the SAPIEN 3 THV||
UK Center for Clinical and Translational Science and nearby locations
- NCT ID
- Edwards Lifesciences
Study ContactVeronica Pettigrew, RN
The purpose of this study is to demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention. In addition patients with dysfunctional THV will be enrolled in a separate registry.