ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
a study on Pulmonary Disease Transcatheter Pulmonary Valve Replacement Tetralogy of Fallot Congenital Heart Defects Pulmonary Regurgitation
Summary
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
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.
Official Title
Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
Keywords
Pulmonary Disease Transcatheter Pulmonary Valve Replacement (TPVR) Tetralogy of Fallot Congenital Heart Disease Pulmonary Regurgitation Respiratory Insufficiency Heart Diseases Pulmonary Valve Insufficiency Edwards Alterra Adaptive Prestent with SAPIEN 3 THV TPVR - PDS Registry
Eligibility
You can join 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 CAN'T join 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
Locations
- University of California, San Francisco
accepting new patients
San Francisco California 94122 United States - Cedars-Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Edwards Lifesciences
- ID
- NCT03130777
- Study Type
- Interventional
- Last Updated
Frequently Asked Questions
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