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

a study on Pulmonary Disease Transpulmonary Valve Replacement Pulmonary Stenosis TPVR Tetralogy of Fallot Congenital Heart Disease

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).

Keywords

Pulmonary Disease Transpulmonary Valve Replacement Pulmonary Stenosis TPVR Tetralogy of Fallot Congenital Heart Disease Heart Diseases Pulmonary Valve Stenosis Edwards Alterra Adaptive Prestent with SAPIEN 3 THV SAPIEN 3 THV

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. The patient has a dysfunctional RVOT/PV.
  4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm and/or 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.

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
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