ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Not Applicable

Active, not recruiting

• Conditions: Transcatheter Pulmonary Valve Replacement (TPVR); Congenital Heart Disease; Tetralogy of Fallot; Pulmonary Regurgitation; Pulmonary Disease
• Interventions: Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

• Registration Number: NCT03130777
• Lead Sponsor: Edwards Lifesciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-26
• Study Start: 2017-08-22
• Primary Completion: 2022-07-14
• Results First Submitted: 2023-07-10
• Results First Submitted QC: 2023-08-07
• Results First Posted: 2023-08-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Study Completion: 2032-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TPVR - Main Cohort	Edwards Alterra Adaptive Prestent with SAPIEN 3 THV	Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
TPVR - PDS Registry	Edwards Alterra Adaptive Prestent with SAPIEN 3 THV	Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).

Primary Outcome Measures

Name	Time	Method
PDS Registry: Acute PDS Success	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
Main Cohort: THV Dysfunction	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

Secondary Outcome Measures

Name	Time	Method
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline	30 days	Number of patients with improvement in total pulmonary regurgitation

Trial Locations

Locations (14)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Emory University/ Children's Healthcare of Atlanta (CHOA); 🇺🇸 Atlanta, Georgia, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Children's Health Dallas; 🇺🇸 Dallas, Texas, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University of Virgina; 🇺🇸 Charlottesville, Virginia, United States