Clincosm LogoSign in Get a demo

ROADMAP: Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01452802
Collaborator
Thoratec Corporation (Industry)
200
Enrollment
52
Locations
56
Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.

Condition or Disease Intervention/Treatment Phase
  • Device: HM II (HeartMate II LVAD)
  • Drug: OMM (Optimal Medical Management)

Detailed Description

The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV symptoms.

The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD. Together with the investigator, the subjects will decide which cohort to enter into at their baseline visit. This study will include experienced HM II LVAD implant centers as well as community centers that care for a large volume of heart failure patients. Study patients will be followed for up to 24 months post enrollment for survival, quality of life and functional status.

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
HM II (HeartMate II LVAD)

Subjects who elect to, and receive HM II LVAD therapy at baseline

Device: HM II (HeartMate II LVAD)
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
Other Names:
  • Left Ventricular Assist Device

    		•
    OMM (Optimal Medical Management)

    Subjects who elect to remain on optimal medical management

    Drug: OMM (Optimal Medical Management)
    Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
    Other Names:
  • Medical Management

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m. [12 months]

    Secondary Outcome Measures

    1. Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint. [6, 12, 18, and 24 months]

    2. Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS) [Baseline and 6, 12, 18 and 24 months]

    3. Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated. [24 months]

    4. Survival in LVAD group free of pump replacement. [24 months]

    5. Quality of Life using the EQ-5D-5L Health Utility Index. [Baseline and 6, 12, 18 and 24 months]

    6. Depression using Patient Health Questionnaire-9 (PHQ-9). [Baseline and 6, 12, 18 and 24 months]

    7. Questionnaire on patient decisions related to LVAD therapy versus optimal medical management. [Baseline and 6, 12, 18 and 24 months]

    8. Functional status using 6MWT distance and NYHA Classification [Baseline and 6, 12, 18 and 24 months]

    9. Incidence of adverse events, rehospitalizations, days alive and not hospitalized. [3, 6, 9, 12, 15, 18, 21 and 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    The following are general criteria; more specific criteria are included in the study protocol:

    Inclusion Criteria:

    • NYHA Class IIIB/IV (refer to Appendix IV for definitions)

    • Left ventricular ejection fraction (LVEF) ≤ 25%

    • Not currently listed for heart transplantation, and not planned in next 12 months

    • On optimal medical management

    • Limited functional status as demonstrated by 6MWT <300 meters

    • At least:

    • One hospitalization for HF in last 12 months or

    • At least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for HF in last 12 months

    Exclusion Criteria:

    • Presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis

    • Platelet count < 100,000/mi within 48 prior to enrollment

    • Any inotrope use within 30 days prior to enrollment

    • Inability to perform 6MWT for any reason

    • Any condition, other than heart failure, that could limit survival to less than 2 years

    • History of cardiac or other organ transplant

    • Existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment

    • Presence of active, uncontrolled, systemic infection

    • History of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%)extracranial stenosis

    • Contraindication to anticoagulation/antiplatelet therapy

    • CRT or CRT-D within 3 months prior to enrollment

    • Coronary revascularization (e.g. CABG, PCI) within 3 months prior to enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baptist Medical Center Little Rock Arkansas United States 72205
    2 Cedars Sinai Medical Center Beverly Hills California United States 90211
    3 Keck Medical Center of USC Los Angeles California United States 90033
    4 Sharp Memorial Hospital San Diego California United States 92123
    5 Stanford University Stanford California United States 94305
    6 Yale New Haven Hospital New Haven Connecticut United States 06510
    7 Shands Hospital at University of Florida Gainesville Florida United States 35610
    8 Tampa General Hospital Tampa Florida United States 33606
    9 Emory University Hospital Atlanta Georgia United States 30322
    10 St. Joseph's Hospital / Atlanta Atlanta Georgia United States 30342
    11 University of Chicago Medical Center Chicago Illinois United States 60637
    12 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
    13 St. Vincent's Hospitals and Health Services Indianapolis Indiana United States 46260
    14 Jewish Hospital Louisville Kentucky United States 40202
    15 Henry Ford Hospital Detroit Michigan United States 48202
    16 Michigan Heart Ypsilanti Michigan United States 48197
    17 Minneapolis Heart Institute Foundation Minneapolis Minnesota United States 55407
    18 University of Minnesota Medical Center Minneapolis Minnesota United States 55455
    19 Mayo Clinic Rochester Rochester Minnesota United States 55905
    20 St. Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    21 Barnes Jewish Hospital Saint Louis Missouri United States 63110
    22 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    23 Mercer Bucks Cardiology Robbinsville New Jersey United States 08691
    24 New Mexico Heart Institute Albuquerque New Mexico United States 87102
    25 Montefiore Medical Center Bronx New York United States 10467
    26 Mt. Sinai Medical Center New York New York United States 10029
    27 Columbia University Medical Center New York New York United States 10032
    28 Hudson Valley Heart Center Poughkeepsie New York United States 12601
    29 University of Rochester Medical Center Rochester New York United States 14642
    30 University of North Carolina Chapel Hill North Carolina United States 27599
    31 Duke University Medical Center Durham North Carolina United States 27710
    32 Sanford Medical Center Fargo North Dakota United States 58122
    33 The Metro Health System Cleveland Ohio United States 44109
    34 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    35 Ohio State University Medical Center Columbus Ohio United States 43210
    36 Riverside Methodist Hospital Columbus Ohio United States 43214
    37 INTEGRIS Baptist Medical Center, Inc. Oklahoma City Oklahoma United States 73112
    38 St. John Medical Center Tulsa Oklahoma United States 74104
    39 Oregon Health and Science University Portland Oregon United States 97239
    40 Abington Memorial Hospital Abington Pennsylvania United States 19001
    41 Penn State Milton Hershey Medical Center Hershey Pennsylvania United States 17033
    42 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    43 Baylor University Medical Center Dallas Texas United States 75226
    44 Memorial Hermann, TMC Houston Texas United States 77030
    45 Methodist Hospital Houston Texas United States 77030
    46 Texas Heart Institute Houston Texas United States 77030
    47 University of Utah Medical School Salt Lake City Utah United States 84132
    48 Inova Fairfax Hospital Falls Church Virginia United States 22042
    49 Virginia Heart Falls Church Virginia United States 22042
    50 Virginia Commonwealth University Richmond Virginia United States 23298
    51 University of Washington Medical Center Seattle Washington United States 98195
    52 St. Luke's Medical Center Milwaukee Wisconsin United States 53233

    Sponsors and Collaborators

    • Abbott Medical Devices
    • Thoratec Corporation

    Investigators

    • Study Director: David Farrar, PhD, Abbott Medical Devices

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01452802
    Other Study ID Numbers:
    • TC07272011
    First Posted:
    Oct 17, 2011
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Abbott Medical Devices
    HeartMate II
    heart-assist device
    medical management
    optimal medical management
    Heart Failure NYHA Class IIIB/IV
    Thoratec Corporation
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 24, 2022