PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
Trial ID or NCT#
NCT02675114
Status
NOT RECRUITING
Purpose
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
Official Title
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Eligibility Criteria
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Severe, calcific aortic stenosis2. New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) \<50%3. Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score \< 44. 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 transcatheter heart valve2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath3. Evidence of an acute myocardial infarction ≤ 30 days before randomization4. Aortic valve is unicuspid, bicuspid, or non-calcified5. Severe aortic regurgitation (\>3+)6. Severe mitral regurgitation (\>3+) ≥ moderate stenosis7. Pre-existing mechanical or bioprosthetic valve in any position8. Complex coronary artery disease:
- 1. Unprotected left main coronary artery 2. Syntax score \> 32 3. Heart Team assessment that optimal revascularization cannot be performed9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization12. Hypertrophic cardiomyopathy with obstruction13. Ventricular dysfunction with LVEF \< 30%14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation15. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure16. Stroke or transient ischemic attack within 90 days of randomization17. Renal insufficiency and/or renal replacement therapy at the time of screening.18. Active bacterial endocarditis within 180 days of randomization19. Severe lung disease or currently on home oxygen20. Severe pulmonary hypertension21. History of cirrhosis or any active liver disease22. Significant frailty as determined by the Heart Team23. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement24. Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation25. Patient refuses blood products26. Body mass index \> 50 kg/m227. Estimated life expectancy \< 24 months28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication29. Immobility that would prevent completion of study procedures30. Patient is not a candidate for both arms of the study31. Currently participating in an investigational drug or another device study.
Investigator(s)
Rahul P Sharma, MBBS, FRACP
Cardiologist,
Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Rajesh Dash, MD PhD; Director of SSATHI & CardioClick
Cardiologist
Associate Professor of Medicine (Cardiovascular Medicine)
View on ClinicalTrials.gov
