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

June 23, 2022 updated by: Abbott Medical Devices

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Medical Center
    • California
      • Beverly Hills, California, United States, 90211
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • Stanford, California, United States, 94305
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • Florida
      • Gainesville, Florida, United States, 35610
        • Shands Hospital at University of Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's Hospital / Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent's Hospitals and Health Services
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital of Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Robbinsville, New Jersey, United States, 08691
        • Mercer Bucks Cardiology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mt. Sinai Medical Center
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Heart Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44109
        • The Metro Health System
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Baptist Medical Center, Inc.
      • Tulsa, Oklahoma, United States, 74104
        • St. John Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
      • Houston, Texas, United States, 77030
        • Memorial Hermann, TMC
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Medical School
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HM II implanting centers and community/referral heart failure clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.
Time Frame: 6, 12, 18, and 24 months
6, 12, 18, and 24 months
Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS)
Time Frame: Baseline and 6, 12, 18 and 24 months
Baseline and 6, 12, 18 and 24 months
Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.
Time Frame: 24 months
24 months
Survival in LVAD group free of pump replacement.
Time Frame: 24 months
24 months
Quality of Life using the EQ-5D-5L Health Utility Index.
Time Frame: Baseline and 6, 12, 18 and 24 months
Baseline and 6, 12, 18 and 24 months
Depression using Patient Health Questionnaire-9 (PHQ-9).
Time Frame: Baseline and 6, 12, 18 and 24 months
Baseline and 6, 12, 18 and 24 months
Questionnaire on patient decisions related to LVAD therapy versus optimal medical management.
Time Frame: Baseline and 6, 12, 18 and 24 months
Baseline and 6, 12, 18 and 24 months
Functional status using 6MWT distance and NYHA Classification
Time Frame: Baseline and 6, 12, 18 and 24 months
Baseline and 6, 12, 18 and 24 months
Incidence of adverse events, rehospitalizations, days alive and not hospitalized.
Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months
3, 6, 9, 12, 15, 18, 21 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 14, 2011

First Posted (Estimate)

October 17, 2011

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC07272011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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