Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

Conditions
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Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies

Intervention / Treatment
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* Device: Left Ventricular Assist System (LVAS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartMate II<br>Implantation of HeartMate II LVAS | Device: Left Ventricular Assist System (LVAS)<br>* Implantation of left ventricular assist device for hemodynamic support<br>* Other names: ventricular assist;|
| Active Comparator: HeartMate XVE<br>Implantation of HeartMate XVE LVAS | Device: Left Ventricular Assist System (LVAS)<br>* Implantation of left ventricular assist device for hemodynamic support<br>* Other names: ventricular assist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint | Survival at two (2) years free of stroke, or reoperation to repair or replace the device | Patients' status at 2 years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Living With Heart Failure Questionnaire(MLWHF) | MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life. | Baseline, Months 1,3,6,12 | 
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life. | Baseline, Months 1, 3, 6, 12 | 
| New York Heart Association (NYHA) Classification | NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort | Baseline, Months 1, 6, 12 | 
| Six Minute Walk Test (6MWT) | The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status. | Baseline, Months 1, 3, 6, 12 | 
| Functional Status (Patient Activity Score) | Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High | Baseline, Months 1, 3, 6, 12 | 
| Reoperations | The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons | Patients were followed until outcome or up to 2 years post-implant, whichever came first | 
| Neurocognitive Assessments, Clock Drawing | Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score. | Baseline (1 month), 6 months | 
| Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better | Baseline (1 month), 6 months | 
| Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better. | Baseline (1 month), 6 months | 
| Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) | The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better. | Baseline (1 month), 6 months | 
| Neurocognitive Assessments, Boston Naming Test | Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better. | Baseline (1 month), 6 months | 
| Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) | The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better. | Baseline (1 month), 6 months | 
| Neurocognitive Assessments, Trail Making A | This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better. | Baseline (1 month), 6 months | 
| Neurocognitive Assessments, Trail Making B | This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better. | Baseline (1 month), 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart-assist devices