ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Not Applicable

Active, not recruiting

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

• Registration Number: NCT03130777
• Lead Sponsor: Edwards Lifesciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-4-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Inclusion Criteria:<br><br> 1. The candidate/candidate's legally authorized representative has been informed of the<br> nature of the study, agrees to its provisions and has provided written informed<br> consent.<br><br> 2. Weight is = 20 kg (44 lbs).<br><br> 3. RVOT/PV with moderate or greater PR by TTE.<br><br> 4. RVOT/PV proximal and distal landing zone diameter = 27 mm and = 38 mm, and minimum<br> of 35 mm from contractile tissue to lowest pulmonary artery takeoff.<br><br>Exclusion Criteria:<br><br> 1. Active infection requiring current antibiotic therapy (if temporary illness, patient<br> may be a candidate 2 weeks after discontinuation of antibiotics).<br><br> 2. History of or active endocarditis (active treatment with antibiotics) within the<br> past 180 days.<br><br> 3. Leukopenia (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets<br> < 50,000 cells/µL) or any known blood clotting disorder.<br><br> 4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent<br> or the SAPIEN 3 THV.<br><br> 5. Need for concomitant atrial septal defect or ventricular septal defect closure or<br> other concomitant interventional procedures other than pulmonary artery or branch<br> pulmonary artery stenting or angioplasty<br><br> 6. Interventional/surgical procedures within 30 days prior to the Alterra or valve<br> implant procedure<br><br> 7. Any planned surgical, percutaneous coronary or peripheral procedure to be performed<br> within the 30 day follow-up from the Alterra or valve implant procedure<br><br> 8. History of or current intravenous drug use<br><br> 9. Major or progressive non-cardiac disease resulting in a life expectancy of less than<br> one year<br><br> 10. Known hypersensitivity to aspirin or heparin and cannot be treated with other<br> antiplatelet and/or antithrombotic medications<br><br> 11. Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that<br> cannot be adequately pre-medicated<br><br> 12. Currently participating in an investigational drug or another device study [Note:<br> Trials requiring extended follow up for products that were investigational, but have<br> since become commercially available, are not considered investigational devices.]<br><br> 13. Positive urine or serum pregnancy test in female patients of child-bearing potential<br><br> 14. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline