ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Running, not enrolling · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03130777

Run by

Edwards Lifesciences

People needed

86

Starts

2017-08-22

Expected to finish

2032-06-01

Last updated by the study team

2025-09-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Emory University/ Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Health Dallas — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Virgina — Charlottesville, Virginia, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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