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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Implantation of left ventricular assist device for hemodynamic support
Composite Endpoint
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Time frame: Patients' status at 2 years post-implant
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado Hospital
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Shands Hospital @ University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
...and 37 more locations
Time frame: Baseline, Months 1, 3, 6, 12
Functional Status (Patient Activity Score)
Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (1 month), 6 months