Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

All candidates for this study must meet all of the following inclusion criteria:

1. Age ≥18 years

2. NYHA class ≥ 2

3. NT-proBNP > 900pg/mL (or BNP > 200 pg/mL) or hospitalization for HF within the 2 years;

Note: To account for the decrease in natriuretic peptide levels with overweight/obesity, NT-proBNP and BNP levels cutoff will be reduced by 4% for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).

4. Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month. o 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.

5. 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.

6. Left ventricular (LV) ejection fraction (EF) < 50% at rest

7. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV

8. 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TAVR (with SAPIEN 3 THV) and OHFT
Transcatheter heart valve and Optimal Heart Failure Therapy
  • Device: SAPIEN 3 THV
  • Biological: Optimal Heart Failure Therapy
Active Comparator
OHFT
Optimal Heart Failure Therapy
  • Device: SAPIEN 3 THV
  • Biological: Optimal Heart Failure Therapy

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Contact:
Ashish Pershad, M.D.
602-478-7052
ashish.pershad@bannerhealth.com

More Details

NCT ID
NCT02661451
Status
Recruiting
Sponsor
Cardiovascular Research Foundation, New York

Study Contact

Ori Ben Yehuda, MD
obenyehuda@crf.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.