Brief Title
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
Official Title
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)
Brief 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.
Study Type
Interventional
Primary Outcome
All-Cause Death
Secondary Outcome
MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of:
Condition
Aortic Valve Stenosis
Intervention
SAPIEN 3 THV
Study Arms / Comparison Groups
TAVR (with SAPIEN 3 THV) and OHFT
Description: Transcatheter heart valve and Optimal Heart Failure Therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
300
Start Date
September 2016
Completion Date
March 2024
Primary Completion Date
March 2023
Eligibility Criteria
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, , [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02661451
Organization ID
TAVR Unload
Responsible Party
Sponsor
Study Sponsor
Cardiovascular Research Foundation, New York
Collaborators
Cardialysis BV
Study Sponsor
, ,
Verification Date
October 2021