ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

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Edwards Lifesciences


Active, not recruiting


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


Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

Study type


Funder types




Details and patient eligibility


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.


86 patients




No Healthy Volunteers

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 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.

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.
  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

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

86 participants in 2 patient groups

TPVR - Main Cohort
Experimental group
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
TPVR - PDS Registry
Experimental group
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

Trial documents

Trial contacts and locations



Data sourced from

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