Aortic Stenosis, Severe, Heart Diseases
Conditions
Keywords
Aortic valve, Asymptomatic, Transcatheter aortic valve replacement
Brief summary
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Detailed description
This is a prospective, randomized, controlled, multicenter study. Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
Interventions
DEVICEEdwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
Sponsors
Edwards Lifesciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 65 years of age or older 2. Severe aortic stenosis 3. Patient is asymptomatic 4. LV ejection fraction ≥ 50% 5. Society of Thoracic Surgeons (STS) risk score ≤ 10 6. 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. Patient is symptomatic 2. Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication. 3. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV 4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 5. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR 6. Evidence of an acute myocardial infarction ≤ 30 days before randomization 7. Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified 8. Severe aortic regurgitation (\>3+) 9. Severe mitral regurgitation (\>3+) or ≥ moderate mitral stenosis 10. Pre-existing mechanical or bioprosthetic valve in any position 11. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization 12. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states 13. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization 14. Hypertrophic cardiomyopathy with obstruction 15. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 16. Inability to tolerate or condition precluding treatment with anti-thrombotic therapy 17. Stroke or transient ischemic attack within 90 days of randomization 18. Renal insufficiency and/or renal replacement therapy 19. Active bacterial endocarditis within 180 days of randomization 20. Severe lung disease or currently on home oxygen 21. Severe pulmonary hypertension 22. History of cirrhosis or any active liver disease 23. Significant frailty as determined by the Heart Team 24. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system 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. Currently participating in an investigational drug or another device study. 30. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death, all stroke, and unplanned cardiovascular hospitalization | When all patients have reached 2-year follow-up | The number of patients that have any of these conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Health | 2 years | Echocardiographic measurements that will assess the health of the left ventricle |
| Change in Left Ventricular Ejection Fraction (LVEF) | 2 years | The average change in LVEF from baseline |
| Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points | 2 years | The number of patients that meet all of these criteria |
| New onset atrial fibrillation | When all patients have reached 2-year follow-up | The number of patients that develop this condition |
| Death or disabling stroke | When all patients have reached 2-year follow-up | The number of patients that have any of these conditions |
Countries
Canada, United States
Outcome results
None listed