COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Edwards Lifesciences
108 participants
Jul 5, 2016
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria14
- 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)
- Interventional/surgical procedures within 30 days prior to the TPVI procedure.
- Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
- History of or current intravenous drug use
- Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
- Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
- Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
- Participating in another investigational drug or device study that has not reached its primary endpoint.
- Female who is lactating or pregnant
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Interventions
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
SAPIEN 3 THV in the pulmonic position
SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Locations(25)
View Full Details on ClinicalTrials.gov
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NCT02744677