The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure, Congestive
- Sponsor
- Abbott Medical Devices
- Enrollment
- 200
- Locations
- 47
- Primary Endpoint
- Composite Endpoint
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
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 cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver. The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Composite Endpoint
Time Frame: Patients' status at 2 years post-implant
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Secondary Outcomes
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline, Months 1, 3, 6, 12)
- Six Minute Walk Test (6MWT)(Baseline, Months 1, 3, 6, 12)
- Functional Status (Patient Activity Score)(Baseline, Months 1, 3, 6, 12)
- Reoperations(Patients were followed until outcome or up to 2 years post-implant, whichever came first)
- Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Trail Making B(Baseline (1 month), 6 months)
- Minnesota Living With Heart Failure Questionnaire(MLWHF)(Baseline, Months 1,3,6,12)
- New York Heart Association (NYHA) Classification(Baseline, Months 1, 6, 12)
- Neurocognitive Assessments, Clock Drawing(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Trail Making A(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)(Baseline (1 month), 6 months)
- Neurocognitive Assessments, Boston Naming Test(Baseline (1 month), 6 months)