PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve
 in patients with severe, calcific aortic stenosis who are at low operative risk for standard
 aortic valve replacement (AVR).
Prospective, randomized, controlled, multi-center trial. Patients having an operative
 mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized
 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3
 or aortic valve replacement with a commercially available surgical bioprosthetic valve.
 Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually
 through 10 years.

 A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional
 patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations
 Registry (UPR) or the Alternative Access Registry.
Inclusion Criteria:

 1. Severe, calcific aortic stenosis

 2. NYHA Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited
 exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with LVEF <50%

 3. Heart team agrees the patient has a risk of operative mortality and has an STS <4

 4. The study patient has been informed of the nature of the study, agrees to its
 provisions and has provided written informed consent.

 Exclusion Criteria:

 1. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV

 2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer
 sheath

 3. Evidence of an acute myocardial infarction ≤ 30 days before randomization

 4. Aortic valve is unicuspid, bicuspid, or non-calcified

 5. Severe aortic regurgitation (>3+)

 6. Severe mitral regurgitation (>3+) ≥ moderate stenosis

 7. Pre-existing mechanical or bioprosthetic valve in any position

 8. Complex coronary artery disease:

 1. Unprotected left main coronary artery

 2. Syntax score > 32

 3. Heart Team assessment that optimal revascularization cannot be performed

 9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
 stenosis within 30 days of randomization

 10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy,
 or hypercoagulable states

 11. Hemodynamic or respiratory instability requiring inotropic support, mechanical
 ventilation or mechanical heart assistance within 30 days of randomization

 12. Hypertrophic cardiomyopathy with obstruction

 13. Ventricular dysfunction with LVEF < 30%

 14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

 15. Inability to tolerate or condition precluding treatment with
 antithrombotic/anticoagulation therapy during or after the valve implant procedure

 16. Stroke or transient ischemic attack within 90 days of randomization

 17. Renal insufficiency and/or renal replacement therapy at the time of screening.

 18. Active bacterial endocarditis within 180 days of randomization

 19. Severe lung disease or currently on home oxygen

 20. Severe pulmonary hypertension

 21. History of cirrhosis or any active liver disease

 22. Significant frailty as determined by the Heart Team

 23. Significant abdominal or thoracic aortic disease that would preclude safe passage of
 the delivery system or cannulation and aortotomy for surgical AVR

 24. Hostile chest or conditions or complications from prior surgery that would preclude
 safe reoperation

 25. Patient refuses blood products

 26. BMI > 50 kg/m2

 27. Estimated life expectancy < 24 months

 28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately
 treated with pre-medication

 29. Immobility that would prevent completion of study procedures

 30. Patient is not a candidate for both arms of the study

 31. Currently participating in an investigational drug or another device study.