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

This study is currently recruiting participants.
Verified May 2013 by Thoratec Corporation
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01452802
First received: October 12, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Heart Failure
 Device: HM II (HeartMate II LVAD)
Drug: OMM (Optimal Medical Management)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HM II implanting centers and community/referral heart failure clinics

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452802

Contacts
Contact: Kelly Bresnahan, BSN 781-272-0139 ext 2936 kelly.bresnahan@thoratec.com
Contact: Kristin Field, BA 781-272-0139 ext 2883 kristin.field@thoratec.com

  Show 50 Study Locations
Sponsors and Collaborators
Thoratec Corporation
Investigators
Study Director: David Farrar, PhD Thoratec Corporation
  More Information

No publications provided

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01452802     History of Changes
Other Study ID Numbers: TC07272011
Study First Received: October 12, 2011
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Thoratec Corporation:
HeartMate II
heart-assist device
medical management
optimal medical management
Heart Failure NYHA Class IIIB/IV

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013