|Principal Investigator: Robert Gray|
|Keywords: Pulmonic Valve Dysfunction , Sapien , THV||Department: Pediatric Cardiology|
|IRB Number: 00091551|
|Specialty: Pediatric Cardiology|
|Recruitment Status: Active, not recruiting|
801 587 7523
To demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
This is a single arm, prospective, multicenter study. A total of 58 subjects will be enrolled at up to 10 investigational sites in the US. (One roll-in patient is allowed per site but not required; roll-in patients will not be counted towards the enrolled sample size.) No site will be allowed to enroll more than 20% of subjects. Subjects will be assessed at the following intervals: screening/baseline, discharge, 30 days, 6 months, 12 months and annually thereafter through 5 years.
The study population will be comprised of subjects with a dysfunctional RVOT conduit or surgical valve that requires pulmonic valve replacement. The enrollment of subjects with a dysfunctional conduit is complete. The remaining enrollment is limited to subjects with a dysfunctional surgical valve.
In addition, up to 50 patients with a dysfunctional THV will be randomly selected by the sponsor and enrolled in a separate registry. No site will be allowed to enroll more than 30% of subjects.
Candidates for this study must meet all of the following 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 (IFU).
3. Subject presents with at least moderate PR and/or mean RVOT gradient > 35 mmHg.
4. The subject/subject’s legally authorized representative (LAR) has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Candidates will be excluded from the study if any of the following conditions are present:
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 (WBC<2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder
4. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV
5. Need for concomitant atrial septal defect (ASD) or ventricular septal defect (VSD) 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. Emergency 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. Currently participating in an investigational drug or another device study. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational devices.
14. Positive urine or serum pregnancy test in female subjects of child-bearing potential