COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency
About this trial
This is an interventional treatment trial for Complex Congenital Heart Defect focused on measuring Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Pulmonary Atresia, Pulmonary Stenosis, Truncus Arteriosus, Transposition of the Great Arteries, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, TPV, TPVR, TPVI
Eligibility Criteria
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 SAPIEN 3 THV
- 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)
- Emergency 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
- Currently participating in an investigational drug or another device study.
- Positive urine or serum pregnancy test in female subjects of child-bearing potential
Sites / Locations
- University of California, Los AngelesRecruiting
- University of California,, San Francisco (UCSF)Recruiting
- Emory University/Children's Healthcare of AtlantaRecruiting
- University of Kentucky
- Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
- Columbia University Medical Center/NYPHRecruiting
- Duke University Medical CenterRecruiting
- The Lindner Research Center at Christ HospitalRecruiting
- Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of PhiladelphiaRecruiting
- Intermountain Heart Institute (IMC)Recruiting
- University of Virginia (UVA)Recruiting
- University of Washington/Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
TPVR - Main Cohort
TPVR - THV Registry
TPVR- S3UR Registry
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).