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Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02661451
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Cardialysis BV
Boston Biomedical Associates LLC
Information provided by (Responsible Party):
Cardiovascular Research Foundation, New York

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: SAPIEN 3 THV Biological: Optimal Heart Failure Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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
Biological: Optimal Heart Failure Therapy



Primary Outcome Measures :
  1. All-Cause Death [ Time Frame: 12 months ]
    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

  2. Disabling Stroke [ Time Frame: 12 months ]
    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

  3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent). [ Time Frame: 12 months ]
    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

  4. Change in KCCQ relative to baseline [ Time Frame: 12 months ]
    Hierarchical occurrence within efficacy assessment time interval (EATI) of:


Secondary Outcome Measures :
  1. 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: [ Time Frame: 12 month ]
    1. All-cause death
    2. Disabling stroke
    3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke or clinically significant worsening of heart failure (heart failure event)

  2. -All-cause death within EATI [ Time Frame: 12 month ]
    -All-cause death within EATI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661451


Contacts
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Contact: Ori Ben Yehuda, MD obenyehuda@crf.org
Contact: Barbara Santiago bsantiago@crf.org

Locations
Show Show 40 study locations
Sponsors and Collaborators
Cardiovascular Research Foundation, New York
Cardialysis BV
Boston Biomedical Associates LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier: NCT02661451    
Other Study ID Numbers: TAVR Unload
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Keywords provided by Cardiovascular Research Foundation, New York:
Valve
Additional relevant MeSH terms:
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Heart Failure
Aortic Valve Stenosis
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction