COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
- Conditions
- Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve DegenerationPulmonary Valve Insufficiency
- Interventions
- Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THVDevice: SAPIEN 3 THVDevice: SAPIEN 3 Ultra RESILIA THV
- Registration Number
- NCT02744677
- Lead Sponsor
- Edwards Lifesciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TPVR - THV Registry SAPIEN 3/SAPIEN 3 Ultra RESILIA THV Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR. TPVR - Main Cohort SAPIEN 3 THV Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). TPVR- S3UR Registry SAPIEN 3 Ultra RESILIA THV Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
- Primary Outcome Measures
Name Time Method THV dysfunction 1 year 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
- Secondary Outcome Measures
Name Time Method THV frame fracture 6 months Device Success Discharge, expected to be within 1-5 days post-procedure 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.
Paravalvular and total PR 6 months RVOT reintervention 6 months Mean RVOT gradient 6 months Major vascular complications 30 days Life-threatening or disabling bleeding 30 days Device-related endocarditis 1 year Coronary artery compression requiring intervention 30 days Death (all-cause, procedural and device-related) 1 year
Trial Locations
- Locations (25)
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of California,, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Childrens Hospital of Colorado
🇺🇸Aurora, Colorado, United States
Emory University/Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Lindner Research Center at Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
LeBonheur Children's Hopsital
🇺🇸Memphis, Tennessee, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
Children's Health System of Texas / UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Methodist San Antonio
🇺🇸San Antonio, Texas, United States
Intermountain Heart Institute (IMC)
🇺🇸Murray, Utah, United States
University of Virginia (UVA)
🇺🇸Charlottesville, Virginia, United States
University of Washington/Seattle Children's Hospital
🇺🇸Seattle, Washington, United States