Status:
COMPLETED
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Thoratec Corporation
Conditions:
Heart Failure, Congestive
Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who...
Detailed Description
The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow...
Eligibility Criteria
Inclusion
- The following are general criteria; more specific conditions are included in the study protocol:
- Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
- On optimal medical management and are failing to respond; or
- In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
- Treated with ACE inhibitors or beta-blockers and found to be intolerant.
- Ineligible for cardiac transplant
- VO2max \<=14 ml/kg/min
- LVEF \<=25%
Exclusion
- The following are general criteria; more specific conditions are included in the study protocol:
- Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
- Existence of factors that would adversely affect patient survival or function of the LVAS
- Intolerance to anticoagulant or antiplatelet therapies.
- Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00121485
Start Date
February 1 2005
End Date
January 1 2012
Last Update
June 27 2022
Active Locations (47)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
3
Sharp Memorial Hospital
San Diego, California, United States, 92123
4
California Pacific Medical Center
San Francisco, California, United States, 94115