RecruitingComplex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve Insufficiency

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Eligible age

All ages

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: Edwards Lifesciences

You may qualify if…

✓ 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.

You may not qualify if…

✕ 1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
✕ 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days
✕ 3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
✕ 4. Inappropriate anatomy for femoral introduction and delivery of the study valve
✕ 5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
✕ 6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
✕ 7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.
✕ 8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.