Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
NCT ID: NCT02661451
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
178 participants
INTERVENTIONAL
2016-09-30
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAVR (with SAPIEN 3 THV) and OHFT
Transcatheter heart valve and Optimal Heart Failure Therapy
SAPIEN 3 THV
Optimal Heart Failure Therapy
OHFT
Optimal Heart Failure Therapy
Optimal Heart Failure Therapy
Interventions
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SAPIEN 3 THV
Optimal Heart Failure Therapy
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Cardialysis BV
INDUSTRY
Avania
INDUSTRY
Cardiovascular Research Foundation, New York
OTHER
Responsible Party
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Locations
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Chandler Regional Medical Center
Chandler, Arizona, United States
UCSD/Sulpizio Cardiovascular Center
La Jolla, California, United States
University of Southern California - Los Angeles
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
St. Joseph Hospital
Orange, California, United States
UCSF
San Francisco, California, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Yale University
New Haven, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Advocate Christ Hospital
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Evanston Hospital/NorthShore Univ. Health System
Evanston, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Ascension St. Mary's Hospital
Saginaw, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
HealthEast Medical Research Institute
Saint Paul, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Morristown Memorial
Morristown, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Oregon Health Science University (OHSU)
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
PinnacleHealth Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
WellSpan York Hospital
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt Heart and Vascular
Nashville, Tennessee, United States
Seton Medical Center Austin
Austin, Texas, United States
IHC Health Services, Inc. dba Intermountain Medical Center
Murray, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Oklahoma Heart Hospital
Milwaukee, Wisconsin, United States
Advocate Aurora- St. Lukes
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
St. Michael's Hospital
Toronto, Ontario, Canada
University Medical Center Utrecht
Utrecht, TH, Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Isala Clinics
Zwolle, , Netherlands
Countries
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References
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Esquitin KA, Khalique OK, Liu Q, Kodali SK, Marcoff L, Nazif TM, George I, Vahl TP, Leon MB, Hahn RT. Accuracy of the Single Cycle Length Method for Calculation of Aortic Effective Orifice Area in Irregular Heart Rhythms. J Am Soc Echocardiogr. 2019 Mar;32(3):344-350. doi: 10.1016/j.echo.2018.11.018. Epub 2019 Jan 28.
Other Identifiers
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TAVR Unload
Identifier Type: -
Identifier Source: org_study_id
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