COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Edwards Lifesciences
Summary
This 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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Weight ≥ 20 kg (44 lbs.) 2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use 3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg. 4. 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. Exclusion Criteria: 1. Active inf…
Interventions
- DeviceSAPIEN 3/SAPIEN 3 Ultra RESILIA THV
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
- DeviceSAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
- DeviceSAPIEN 3 Ultra RESILIA THV
SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Locations (25)
- Arkansas Children's HospitalLittle Rock, Arkansas
- University of California, Los AngelesLos Angeles, California
- University of California,, San Francisco (UCSF)San Francisco, California
- Childrens Hospital of ColoradoAurora, Colorado
- Emory University/Children's Healthcare of AtlantaAtlanta, Georgia
- University of KentuckyLexington, Kentucky