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.
Weight ≥ 20 kg (44 lbs.)
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
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, anemia, thrombocytopenia or any known blood clotting disorder
Inappropriate anatomy for femoral introduction and delivery of the study valve
Single group
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
DeviceSAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
SAPIEN 3 THV
DeviceSAPIEN 3 THV in the pulmonic position
SAPIEN 3 Ultra RESILIA THV
DeviceSAPIEN 3 Ultra RESILIA THV in the pulmonic position
THV dysfunction
Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE
Device Success
Defined as a composite of: 1) Single THV implanted in the desired location, 2) RV-PA peak-to-peak gradient \< 35 mmHg post-implantation, 3) Less than moderate PR by discharge TTE (or earliest evaluable TTE), 4) Free of explant at 24 hours post-implantation.
Mean RVOT gradient
Paravalvular and total PR
RVOT reintervention
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