Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
Conditions
Keywords
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
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.
Interventions
DEVICESAPIEN 3/SAPIEN 3 Ultra RESILIA THV
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
DEVICESAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
DEVICESAPIEN 3 Ultra RESILIA THV
SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Sponsors
Edwards Lifesciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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. 9. History of or current intravenous drug use 10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year 11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications 12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated 13. Participating in another investigational drug or device study that has not reached its primary endpoint. 14. Female who is lactating or pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Mean RVOT gradient | 6 months | — |
| Paravalvular and total PR | 6 months | — |
| RVOT reintervention | 6 months | — |
| Coronary artery compression requiring intervention | 30 days | — |
| Major vascular complications | 30 days | — |
| Life-threatening or disabling bleeding | 30 days | — |
| THV frame fracture | 6 months | — |
| Device-related endocarditis | 1 year | — |
| Death (all-cause, procedural and device-related) | 1 year | — |
Countries
United States
Contacts
CONTACTEdwards THV Clinical Affairs
PRINCIPAL_INVESTIGATORD. Scott Lim, MD
University of Virginia Medical Center
PRINCIPAL_INVESTIGATORVasilis Babaliaros, MD
Emory University Hospitals
Outcome results
None listed