Ensayos clínicos

Inclusion Criteria:

• Age ≥ 18 years.
• Heart Failure with NYHA class ≥ 2.
• Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month prior to randomization.
  • Note: Patients are expected to be on appropriate pharmacologic therapy and if indicated CRT for heart failure. Patients with aortic stenosis may not be able to tolerate maximal doses of heart failure medications and no specific guidelines exist for the medical treatment of heart failure in the setting of aortic stenosis. It is expected that the heart failure PI will review the medical therapy and confirm that it is appropriate for the patient’s condition.
    • Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve area (AVA) > 1.0 cm^2 and ≤ 1.5 cm^2 on rest echo or if ≤ 1.0 cm^2 at rest and low-flow AS is suspected when the an AVA > 1.0 cm^2 with low dose dobutamine stress echo (DSE). Patients with AVA0.6 cm^2 /m^2 on either rest or DSE are also eligible. Similarly, patients with AVA > 1.5 cm^2 but with indexed AVA 1.0 cm^2 and ≤ 1.5 cm^2 (or AVA < 1.0 cm^2 but indexed AVA  > 0.6 cm^2 ) at rest; OR
    • Mean trans-aortic gradient (MG) ≥  20 mmHg and < 40 mmHg and aortic valve area (AVA) ≤ 1.0 cm^2 at rest AND MG < 40 mmHg and aortic valve area (AVA) > 1.0 cm^2 (or AVA < 1.0 cm^2 but indexed AVA > 0.6 cm^2 ) with low dose dobutamine stress echo (DSE).
• In atypical cases (for example mean gradient is below 20 mmHg but valve area is consistent with moderate AS or in case of BSA being elevated due to obesity), the final eligibility determination in regardsto diagnosis of moderate AS will be made by the echocardiographic core lab. In indeterminate cases calcium score may also be used to inform the presence of moderate AS.
• Left ventricular (LV) ejection fraction (EF) < 50% at rest.
• Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV.
• Able to provide independent informed consent (ie, not requiring a legally authorized representative)

Exclusion Criteria:

• LVEF < 20% or persistent need for intravenous inotropic support.
• Hospitalization for acute decompensated HF within 2 weeks prior to randomization.
• Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to randomization.
• Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization.
• In need and suitable for revascularization per heart team consensus.
• Severe aortic and/or mitral regurgitation.
• Congenital unicuspid or congenital bicuspid aortic valve.
• Concomitant non-aortic valvular disease with a formal indication for valve surgery per established guidelines (ESC/ACC/AHA).
• Previous aortic valve replacement (mechanical or bioprosthetic).
• Severe RV dysfunction.
• Previous stroke with permanent disability (modified Rankin score ≥ 2).
• Severe lung disease as indicated by FEV1 < 30% predicted or need for chronic daytime supplemental oxygen therapy.
• Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or need for renal replacement therapy.
• Gastrointestinal (GI) bleeding within the past 3 months.
• Liver cirrhosis Child-Pugh C.
• Active systemic infection, including active endocarditis.
• Unwilling to accept blood transfusion.
• Evidence of intracardiac mass, thrombus, or vegetation.
• Absence of minimum amount of aortic valve calcification necessary for TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV.
• Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral anticoagulation if indicated (e.g. subject in atrial fibrillation).
• Sensitivity to contrast media which cannot be adequately pre-medicated.
• Women of child-bearing potential.
• Clinical signs of dementia.
• Other medical, social, or psychological conditions that precludes appropriate consent and follow-up.
• Life expectancy < 2 years due to cancer or other noncardiac chronic diseases.
• Unwillingnessto undergo follow-up investigations.
• Currently participating in an investigational drug or another device trial that has not reached its primary endpoint (excluding registries).

Eligibility last updated 12/10/21. Questions regarding updates should be directed to the study team contact.