COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary V… (NCT02744677) | Clinical Trial Compass
RecruitingNot Applicable
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
United States108 participantsStarted 2016-07-05
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕. 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
✕. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)