ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

NCT ID: NCT03130777

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-22
• Study Completion Date: 2032-06-30

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TPVR - Main Cohort

Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.

Group Type: EXPERIMENTAL

Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

Intervention Type: 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.

TPVR - PDS Registry

Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).

Group Type: EXPERIMENTAL

Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

Intervention Type: 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.

Interventions

Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Zahn, MD, FACC, FSCAI

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Heart Institute

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-04

Identifier Type: -

Identifier Source: org_study_id