Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The objective of this study is to determine the safety and efficacy of transcatheter aortic
valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as
compared with OHFT.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Other
Enrollment Eligibility
Inclusion Criteria
All candidates for this study must meet all of the following inclusion criteria:
1. Age ≥18 years
2. Heart Failure with NYHA class ≥ 2
3. 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. (12, 13) 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.
4. Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve
area (AVA) >1.0 cm2 and ≤1.5 cm2 on rest echo or if ≤1.0 cm2 at rest and low-flow AS
is suspected when the an AVA > 1.0 cm2 with low dose dobutamine stress echo (DSE).
Patients with AVA<1.0 cm2 but with an indexed AVA of >0.6 cm2/m2 on either rest or DSE
are also eligible. Similarly, patients with AVA >1.5 cm2 but with indexed AVA<0.9
cm2/m2 on either rest of DSE are also eligible.
Note: Typically such cases will demonstrate,
• Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg at rest and aortic valve
area (AVA) > 1.0 cm2 and ≤1.5 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) at rest
OR
• Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg and aortic valve area (AVA)
≤1.0 cm2 at rest AND MG < 40 mmHg and aortic valve area (AVA)
•>1.0 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) 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, the final eligibility determination in regards to
diagnosis of moderate AS will be made by the echocardiographic core lab.
5. Left ventricular (LV) ejection fraction (EF) < 50% at rest
6. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV
7. Able to provide independent informed consent (i.e., not requiring a legally authorized
representative)
Exclusion Criteria
Candidates are excluded from the study if any of the following conditions are present:
1. LVEF < 20% or persistent need for intravenous inotropic support
2. Hospitalization for acute decompensated HF within 2 weeks prior to randomization
3. Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to
randomization
4. Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization
5. In need and suitable for revascularization per heart team consensus
6. Severe aortic and/or mitral regurgitation
7. Congenital unicuspid or congenital bicuspid aortic valve
8. Concomitant non-aortic valvular disease with a formal indication for valve surgery per
established guidelines (ESC/ACC/AHA)
9. Previous aortic valve replacement (mechanical or bioprosthetic)
10. Severe RV dysfunction
11. Previous stroke with permanent disability (modified Rankin score ≥ 2)
12. Severe lung disease as indicated by FEV1 <30% predicted or need for chronic daytime
supplemental oxygen therapy
13. Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or
need for renal replacement therapy
14. Gastrointestinal (GI) bleeding within the past 3 months
15. Liver cirrhosis Child-Pugh C
16. Active systemic infection, including active endocarditis
17. Unwilling to accept blood transfusion
18. Evidence of intracardiac mass, thrombus or vegetation
19. Absence of minimum amount of aortic valve calcification necessary for TAVR with the
SAPIEN 3 or SAPIEN 3 Ultra THV
20. Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral
anticoagulation if indicated (e.g. subject in atrial fibrillation)
21. Sensitivity to contrast media which cannot be adequately pre-medicated
22. Women of child-bearing potential
23. Clinical signs of dementia
24. Other medical, social, or psychological conditions that precludes appropriate consent
and follow-up
25. Life expectancy < 2 years due to cancer or other non-cardiac chronic diseases
26. Unwillingness to undergo follow-up investigations
27. Currently participating in an investigational drug or another device trial that has
not reached its primary endpoint (excluding registries)