This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    tavr unload
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Cardiovascular Research Foundation, New York
Sponsor:
Collaborators:
Cardialysis BV
Boston Biomedical Associates LLC
Information provided by (Responsible Party):
Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier:
NCT02661451
First received: January 15, 2016
Last updated: August 1, 2017
Last verified: August 2017
  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 Intervention
Aortic Valve Stenosis Device: SAPIEN 3 THV Biological: Optimal Heart Failure Therapy

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Cardiovascular Research Foundation, New York:

Primary Outcome Measures:
  • All-Cause Death within 12 months [ Time Frame: 12 months ]

    Hierarchical occurrence within one year of:

    1. All-cause death
    2. Disabling Stroke
    3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke
    4. Change in KCCQ relative to baseline

  • Disabling Stroke within 12 months [ Time Frame: 12 months ]

    Hierarchical occurrence within one year of:

    1. All-cause death
    2. Disabling Stroke
    3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke
    4. Change in KCCQ relative to baseline

  • Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke within 12 months [ Time Frame: 12 months ]

    Hierarchical occurrence within one year of:

    1. All-cause death
    2. Disabling Stroke
    3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke
    4. Change in KCCQ relative to baseline

  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) relative to baseline within 12 months [ Time Frame: 12 months ]

    Hierarchical occurrence within one year of:

    1. All-cause death
    2. Disabling Stroke
    3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke
    4. Change in KCCQ relative to baseline


Secondary Outcome Measures:
  • Composite of all-cause death, disabling stroke and renal replacement therapy at 30 days, 6 months and 12 months [ Time Frame: 30 days, 6 months and 1 year ]
    Composite of all-cause death, disabling stroke and renal replacement therapy


Estimated Enrollment: 600
Actual Study Start Date: September 2016
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Inclusion Criteria:

Candidates are excluded from the study if any of the following conditions are present:

  1. Age ≥18 years
  2. NYHA class ≥ 2
  3. NT-proBNP > 1500 pg/mL (or BNP > 400 pg/mL) or hospitalization for HF within the last year
  4. Under appropriate guideline-directed HF therapy (including cardiac resynchronization therapy) for a minimum of 3 months.

    -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 an AVA > 1.0 cm2 with low dose dobutamine stress echo (DSE). Patients with AVA<1.0 cm2 but with an indexed AVA of >0.6cm2 on either rest or 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 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 3 months prior to randomization
  4. Coronary artery revascularization (PCI or CABG) within 3 months 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. Chronic obstructive pulmonary disease (COPD) GOLD 4 (FEV1 <30% predicted, <50% predicted with chronic respiratory failure present (long-term oxygen therapy), or FEV1/FVC <0.70)
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02661451

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

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sammy Elmariah, MD    617-726-6120    selmariah@mgh.harvard.edu   
United States, New York
Columbia University Medical Center/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Susheel K. Kodali, M.D.    212-305-7060    sk2427@cumc.columbia.edu   
United States, Ohio
Lindner Research Center - The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dean Kereiakes, M.D.    513-585-1777    LindnerMD@thechristhospital.com   
United States, Pennsylvania
PinnacleHealth Cardiovascular Institute Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Hemal Gada, M.D.    314-308-3288    hgada@pinnaclehealth.org   
WellSpan York Hospital Recruiting
York, Pennsylvania, United States, 17405
Contact: William Nicholson, M.D.    717-851-2441    wjnichmd2@aol.com   
United States, Utah
IHC Health Services, Inc. dba Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Brian Whisenant, MD    801-507-3559    Brian.Whisenant@imail.org   
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Harold Dauerman, MD    802-847-3602    Harold.Dauerman@uvmhealth.org   
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Nicolas M. Van Mieghem, MD, PhD    0031(0)107035260    n.vanmieghem@erasmusmc.nl   
Sponsors and Collaborators
Cardiovascular Research Foundation, New York
Cardialysis BV
Boston Biomedical Associates LLC
  More Information

Responsible Party: Cardiovascular Research Foundation, New York
ClinicalTrials.gov Identifier: NCT02661451     History of Changes
Other Study ID Numbers: TAVR Unload
Study First Received: January 15, 2016
Last Updated: August 1, 2017

Keywords provided by Cardiovascular Research Foundation, New York:
Valve

Additional relevant MeSH terms:
Heart Failure
Aortic Valve Stenosis
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 21, 2017