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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
All-Cause Death — 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Disabling Stroke — 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent). — 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Change in KCCQ relative to baseline — 12 months Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Trial sites (51)
Facility
City
Region
Status
Chandler Regional Medical Center
Chandler
Arizona
UCSD/Sulpizio Cardiovascular Center
La Jolla
California
University of Southern California - Los Angeles
Los Angeles
California
UCLA Medical Center
Los Angeles
California
St. Joseph Hospital
Orange
California
UCSF
San Francisco
California
Medical Center of the Rockies
Loveland
Colorado
Yale University
New Haven
Connecticut
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
University of Miami
Miami
Florida
Cleveland Clinic Florida
Weston
Florida
Advocate Christ Hospital
Chicago
Illinois
Northwestern University
Chicago
Illinois
Alexian Brothers Medical Center
Elk Grove Village
Illinois
Evanston Hospital/NorthShore Univ. Health System
Evanston
Illinois
Advocate Lutheran General Hospital
Park Ridge
Illinois
Carle Foundation Hospital
Urbana
Illinois
Maine Medical Center
Portland
Maine
Tufts Medical Center
Boston
Massachusetts
Massachusetts General Hospital
Boston
Massachusetts
Beaumont Hospital
Royal Oak
Michigan
Ascension St. Mary's Hospital
Saginaw
Michigan
Minneapolis Heart Institute
Minneapolis
Minnesota
Mayo Clinic - Rochester
Rochester
Minnesota
HealthEast Medical Research Institute
Saint Paul
Minnesota
Washington University in St. Louis
St Louis
Missouri
University of Nebraska Medical Center
Omaha
Nebraska
Morristown Memorial
Morristown
New Jersey
NYU Langone Medical Center
New York
New York
Columbia University Medical Center/New York Presbyterian Hospital
New York
New York
St. Francis Hospital
Roslyn
New York
Oregon Health Science University (OHSU)
Portland
Oregon
University of Pennsylvania
Philadelphia
Pennsylvania
UPMC Presbyterian
Pittsburgh
Pennsylvania
PinnacleHealth Cardiovascular Institute
Wormleysburg
Pennsylvania
WellSpan York Hospital
York
Pennsylvania
Rhode Island Hospital
Providence
Rhode Island
Vanderbilt Heart and Vascular
Nashville
Tennessee
Seton Medical Center Austin
Austin
Texas
IHC Health Services, Inc. dba Intermountain Medical Center
Murray
Utah
+ 11 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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