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

Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Age Range:Any
Start Date:August 22, 2017
End Date:October 2024
Contact:Erika Tequia

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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).

Inclusion Criteria:

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

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.

Exclusion Criteria:

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.
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