Status:
COMPLETED
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Thoratec Corporation
Conditions:
Heart Failure, Congestive
Ventricular Dysfunction
Eligibility:
All Genders
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 a bridge to cardiac transplantation in end-stage heart fail...
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:
- Listed for cardiac transplantation
- NYHA Class IV heart failure symptoms
- On inotropic support, if tolerated
- Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock
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 :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00121472
Start Date
March 1 2005
End Date
May 1 2010
Last Update
June 27 2022
Active Locations (36)
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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