ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
1 other identifier
interventional
86
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedStudy Start
First participant enrolled
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2022
CompletedResults Posted
Study results publicly available
August 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2032
ExpectedSeptember 25, 2025
September 1, 2025
4.9 years
April 24, 2017
July 10, 2023
September 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
30 days
Study Arms (2)
TPVR - Main Cohort
EXPERIMENTALImplantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
TPVR - PDS Registry
EXPERIMENTALImplantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94122, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Emory University/ Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30322, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Health Dallas
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Virgina
Charlottesville, Virginia, 22908, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Research
- Organization
- Edwards Lifesciences
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Zahn, MD, FACC, FSCAI
Cedars-Sinai Heart Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2017
First Posted
April 26, 2017
Study Start
August 22, 2017
Primary Completion
July 14, 2022
Study Completion (Estimated)
June 1, 2032
Last Updated
September 25, 2025
Results First Posted
August 8, 2023
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share