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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 May 2013 |
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Main ID: |
NCT01452802 |
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Date of registration:
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12/10/2011 |
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Primary sponsor: |
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Public title:
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Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
ROADMAP |
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Scientific title:
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Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01452802 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Kelly Bresnahan, BSN |
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Address:
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Telephone:
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781-272-0139 |
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Email:
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kelly.bresnahan@thoratec.com |
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Affiliation:
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Name:
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David Farrar, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thoratec Corporation |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Device: HM II (HeartMate II LVAD)
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Drug: OMM (Optimal Medical Management)
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Primary Outcome(s)
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Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of = 75m.
[Time Frame: 12 months]
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Secondary Outcome(s)
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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]
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Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.
[Time Frame: 24 months]
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Depression using Patient Health Questionnaire-9 (PHQ-9).
[Time Frame: Baseline and 6, 12, 18 and 24 months]
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Functional status using 6MWT distance and NYHA Classification
[Time Frame: Baseline and 6, 12, 18 and 24 months]
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Incidence of adverse events, rehospitalizations, days alive and not hospitalized.
[Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months]
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Quality of Life using the EQ-5D-5L Health Utility Index.
[Time Frame: Baseline and 6, 12, 18 and 24 months]
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Questionnaire on patient decisions related to LVAD therapy versus optimal medical management.
[Time Frame: Baseline and 6, 12, 18 and 24 months]
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Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.
[Time Frame: 6, 12, 18, and 24 months]
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Survival in LVAD group free of pump replacement.
[Time Frame: 24 months]
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Secondary ID(s)
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TC07272011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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