Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Official Title

Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

Keywords

Pulmonary Disease Transcatheter Pulmonary Valve Replacement (TPVR) Tetralogy of Fallot Congenital Heart Disease Pulmonary Regurgitation Respiratory Insufficiency Heart Diseases Pulmonary Valve Insufficiency Edwards Alterra Adaptive Prestent with SAPIEN 3 THV TPVR - PDS Registry

Eligibility

You can join if…

  1. The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  2. Weight is ≥ 20 kg (44 lbs).
  3. RVOT/PV with moderate or greater PR by TTE.
  4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.

You CAN'T join if...

  1. Active infection requiring current antibiotic therapy (if temporary illness, patient 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 introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
  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. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure
  7. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure
  8. History of or current intravenous drug use
  9. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
  10. . Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
  11. . Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated
  12. . 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.]
  13. . Positive urine or serum pregnancy test in female patients of child-bearing potential
  14. . Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94122 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT03130777
Study Type
Interventional
Last Updated