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.
Brief Title
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure
Eligibility 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
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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
HeartMate II
heart-assist device
medical management
optimal medical management
Heart Failure NYHA Class IIIB/IV
Thoratec Corporation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT01452802
Org Class
Industry
Org Full Name
Abbott Medical Devices
Org Study Id
TC07272011
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
Primary Outcomes
Outcome Measure
Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Time Frame
6, 12, 18, and 24 months
Outcome Measure
Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.
Outcome Time Frame
Baseline and 6, 12, 18 and 24 months
Outcome Measure
Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS)
Outcome Time Frame
24 months
Outcome Measure
Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.
Outcome Time Frame
24 months
Outcome Measure
Survival in LVAD group free of pump replacement.
Outcome Time Frame
Baseline and 6, 12, 18 and 24 months
Outcome Measure
Quality of Life using the EQ-5D-5L Health Utility Index.
Outcome Time Frame
Baseline and 6, 12, 18 and 24 months
Outcome Measure
Depression using Patient Health Questionnaire-9 (PHQ-9).
Outcome Time Frame
Baseline and 6, 12, 18 and 24 months
Outcome Measure
Questionnaire on patient decisions related to LVAD therapy versus optimal medical management.
Outcome Time Frame
Baseline and 6, 12, 18 and 24 months
Outcome Measure
Functional status using 6MWT distance and NYHA Classification
Outcome Time Frame
3, 6, 9, 12, 15, 18, 21 and 24 months
Outcome Measure
Incidence of adverse events, rehospitalizations, days alive and not hospitalized.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
HM II implanting centers and community/referral heart failure clinics
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Goldstein
Investigator Email
dgoldste@montefiore.org
Investigator Phone