Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Edwards Lifesciences
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
