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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03130777
Other study ID # 2016-04
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 22, 2017
Est. completion date June 2032

Study information

Verified date August 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 86
Est. completion date June 2032
Est. primary completion date July 14, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Intervention

Device:
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.

Locations

Country Name City State
United States Emory University/ Children's Healthcare of Atlanta (CHOA) Atlanta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States University of Virgina Charlottesville Virginia
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Children's Health Dallas Dallas Texas
United States Texas Children's Hospital Houston Texas
United States Cedars-Sinai Medical Center Los Angeles California
United States University of California, Los Angeles Los Angeles California
United States Columbia University Medical Center New York New York
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States St. Louis Children's Hospital Saint Louis Missouri
United States University of California, San Francisco San Francisco California
United States Seattle Children's Hospital Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline Number of patients with improvement in total pulmonary regurgitation 30 days
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