Status:
COMPLETED
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Thoratec Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18-85 years
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 failu...
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. Th...
Eligibility Criteria
Inclusion
- The following are general criteria; more specific criteria are included in the study protocol:
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01452802
Start Date
October 1 2011
End Date
June 1 2016
Last Update
June 24 2022
Active Locations (52)
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1
Baptist Medical Center
Little Rock, Arkansas, United States, 72205
2
Cedars Sinai Medical Center
Beverly Hills, California, United States, 90211
3
Keck Medical Center of USC
Los Angeles, California, United States, 90033
4
Sharp Memorial Hospital
San Diego, California, United States, 92123