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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01452802
First received: October 12, 2011
Last updated: July 31, 2014
Last verified: July 2014

October 12, 2011
July 31, 2014
October 2011
December 2015   (final data collection date for primary outcome measure)
Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01452802 on ClinicalTrials.gov Archive Site
  • Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint. [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Survival in LVAD group free of pump replacement. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of Life using the EQ-5D-5L Health Utility Index. [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Depression using Patient Health Questionnaire-9 (PHQ-9). [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Questionnaire on patient decisions related to LVAD therapy versus optimal medical management. [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Functional status using 6MWT distance and NYHA Classification [ Time Frame: Baseline and 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events, rehospitalizations, days alive and not hospitalized. [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

HM II implanting centers and community/referral heart failure clinics

Heart Failure
  • 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 Name: Left Ventricular Assist Device
  • 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 Name: Medical Management
  • HM II (HeartMate II LVAD)
    Subjects who elect to, and receive HM II LVAD therapy at baseline
    Intervention: Device: HM II (HeartMate II LVAD)
  • OMM (Optimal Medical Management)
    Subjects who elect to remain on optimal medical management
    Intervention: Drug: OMM (Optimal Medical Management)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01452802
TC07272011
No
Thoratec Corporation
Thoratec Corporation
Not Provided
Study Director: David Farrar, PhD Thoratec Corporation
Thoratec Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP