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Active, Not Recruiting

NCT Number: NCT03130777

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Lung Diseases Pulmonary Regurgitation Pulmonary Valve Insufficiency Respiratory Tract Diseases Tetralogy of Fallot Transcatheter Pulmonary Valve Replacement (TPVR)

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

Device

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.

Primary outcomes

  1. Main Cohort: THV Dysfunction

    Time frame: 6 months

    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

  2. PDS Registry: Acute PDS Success

    Time frame: 24 hours

    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

Secondary outcomes

  1. Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline

    Time frame: 30 days

    Number of patients with improvement in total pulmonary regurgitation

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2032
First posted
Apr 26, 2017
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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