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

Sponsor
Cardiovascular Research Foundation, New York (Other)
Overall Status
Recruiting
CT.gov ID
NCT02661451
Collaborator
Cardialysis BV (Industry), Avania (Industry)
300
Enrollment
56
Locations
2
Arms
90
Anticipated Duration (Months)
5.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: SAPIEN 3 THV
  • Biological: Optimal Heart Failure Therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. All-Cause Death [12 months]

    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

  2. Disabling Stroke [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). [12 months]

    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

  4. Change in KCCQ relative to baseline [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: [12 month]

    All-cause death Disabling stroke 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 [12 month]

    -All-cause death within EATI

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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. 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.

  1. 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.

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

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

  3. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chandler Regional Medical Center Chandler Arizona United States 85224
2 Banner University Medical Center Phoenix Phoenix Arizona United States 85006
3 UCSD/Sulpizio Cardiovascular Center La Jolla California United States 92037
4 University of Southern California - Los Angeles Los Angeles California United States 90033
5 UCLA Medical Center Los Angeles California United States 90095
6 St. Joseph Hospital Orange California United States 92868
7 UCSF San Francisco California United States 94143
8 Medical Center of the Rockies Loveland Colorado United States 80538
9 Hartford Hospital Hartford Connecticut United States 06112
10 Yale University New Haven Connecticut United States 06520
11 Medstar Washington Hospital Center Washington District of Columbia United States 20010
12 University of Miami Miami Florida United States 33136
13 Cleveland Clinic Florida Weston Florida United States 33331
14 Emory University Hospital Atlanta Georgia United States 30322
15 Advocate Christ Hospital Chicago Illinois United States 60453
16 Northwestern University Chicago Illinois United States 60611
17 Alexian Brothers Medical Center Elk Grove Village Illinois United States 60007
18 Evanston Hospital/NorthShore Univ. Health System Evanston Illinois United States 60210
19 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
20 Carle Foundation Hospital Urbana Illinois United States 61801
21 Maine Medical Center Portland Maine United States 04102
22 Tufts Medical Center Boston Massachusetts United States 02111
23 Massachusetts General Hospital Boston Massachusetts United States 02114
24 Beaumont Hospital Royal Oak Michigan United States 48072
25 Ascension St. Mary's Hospital Saginaw Michigan United States 48601
26 Minneapolis Heart Institute Minneapolis Minnesota United States
27 Mayo Clinic - Rochester Rochester Minnesota United States 55905
28 HealthEast Medical Research Institute Saint Paul Minnesota United States 55102
29 Washington University in St. Louis Saint Louis Missouri United States 63110
30 University of Nebraska Medical Center Omaha Nebraska United States 68198
31 Morristown Memorial Morristown New Jersey United States 07962
32 NYU Langone Medical Center New York New York United States 10016
33 Columbia University Medical Center/New York Presbyterian Hospital New York New York United States 10032
34 St. Francis Hospital Roslyn New York United States 11576
35 Oregon Health Science University (OHSU) Portland Oregon United States 97239
36 University of Pennsylvania Philadelphia Pennsylvania United States 19104
37 UPMC Presbyterian Pittsburgh Pennsylvania United States 15213
38 PinnacleHealth Cardiovascular Institute Wormleysburg Pennsylvania United States 17043
39 WellSpan York Hospital York Pennsylvania United States 17405
40 Rhode Island Hospital Providence Rhode Island United States 02904
41 Vanderbilt Heart and Vascular Nashville Tennessee United States 37203
42 Seton Medical Center Austin Austin Texas United States 78705
43 The Heart Hospital Baylor Plano Plano Texas United States 75093
44 IHC Health Services, Inc. dba Intermountain Medical Center Murray Utah United States 84107
45 University of Vermont Medical Center Burlington Vermont United States 05401
46 Virginia Commonwealth University (VCU) Richmond Virginia United States 23298
47 Swedish Medical Center Seattle Washington United States 98125
48 Oklahoma Heart Hospital Milwaukee Wisconsin United States 53211
49 Advocate Aurora- St. Lukes Milwaukee Wisconsin United States 53215
50 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
51 St. Michael's Hospital Toronto Ontario Canada M5B 1W8
52 Quebec Heart and Lung Institute Québec Canada G1V 4G5
53 University Medical Center Utrecht Utrecht TH Netherlands 3584CX
54 Leiden University Medical Center Leiden Netherlands
55 Erasmus Medical Center Rotterdam Netherlands
56 Isala Clinics Zwolle Netherlands

Sponsors and Collaborators

  • Cardiovascular Research Foundation, New York
  • Cardialysis BV
  • Avania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier:
NCT02661451
Other Study ID Numbers:
  • TAVR Unload
First Posted:
Jan 22, 2016
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Cardiovascular Research Foundation, New York
Valve
Additional relevant MeSH terms:
Heart Failure
Aortic Valve Stenosis

Study Results

No Results Posted as of Nov 1, 2021