ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Study Overview
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Brief Summary
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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). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

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

Conditions
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Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation

Intervention / Treatment
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* Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Weight is ≥ 20 kg (44 lbs). RVOT/PV with moderate or greater PR by TTE. 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. Exclusion Criteria: Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics). History of or active endocarditis (active treatment with antibiotics) within the past 180 days. Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV. 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 Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure History of or current intravenous drug use Major or progressive non-cardiac disease resulting in a life expectancy of less than one year Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated 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.] Positive urine or serum pregnancy test in female patients of child-bearing potential Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, prospective, multi-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPVR - Main Cohort<br>Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System. | Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV<br>* The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.<br>|
| Experimental: TPVR - PDS Registry<br>Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS). | Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV<br>* The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Cohort: THV Dysfunction | Number of patients with THV dysfunction, defined as a non-hierarchical composite of: RVOT/PV Reintervention Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) Mean RVOT/PV Gradient >= 35mmHg via TTE | 6 months | 
| PDS Registry: Acute PDS Success | Number of patients with acute PDS success, defined as a non-hierarchical composite of: Single THV implanted in the desired location Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient < 35 mmHg post-THV implantation Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline | Number of patients with improvement in total pulmonary regurgitation | 30 days |