Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management (ROADMAP)
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|ClinicalTrials.gov Identifier: NCT01452802|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : June 13, 2016
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: HM II (HeartMate II LVAD) Drug: OMM (Optimal Medical Management)|
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|
|Actual Enrollment :||200 participants|
|Official Title:||Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||June 2016|
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
- Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m. [ Time Frame: 12 months ]
- Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint. [ Time Frame: 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 ]
- Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated. [ Time Frame: 24 months ]
- Survival in LVAD group free of pump replacement. [ Time Frame: 24 months ]
- Quality of Life using the EQ-5D-5L Health Utility Index. [ Time Frame: 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 ]
- Questionnaire on patient decisions related to LVAD therapy versus optimal medical management. [ Time Frame: 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 ]
- Incidence of adverse events, rehospitalizations, days alive and not hospitalized. [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452802
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|Study Director:||David Farrar, PhD||St. Jude Medical|