Cardiomyopathies, Heart Failure, Congestive, Ventricular Dysfunction
Conditions
Keywords
Heart-assist devices
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.
Interventions
Implantation of left ventricular assist device for hemodynamic support
Sponsors
Thoratec Corporation
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint | Patients' status at 2 years post-implant | Survival at two (2) years free of stroke, or reoperation to repair or replace the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline, Months 1, 3, 6, 12 | 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. |
| New York Heart Association (NYHA) Classification | Baseline, Months 1, 6, 12 | 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 |
| Six Minute Walk Test (6MWT) | Baseline, Months 1, 3, 6, 12 | 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. |
| Functional Status (Patient Activity Score) | Baseline, Months 1, 3, 6, 12 | Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High |
| Reoperations | Patients were followed until outcome or up to 2 years post-implant, whichever came first | 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 |
| Neurocognitive Assessments, Clock Drawing | Baseline (1 month), 6 months | 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. |
| Minnesota Living With Heart Failure Questionnaire(MLWHF) | Baseline, Months 1,3,6,12 | 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. |
| Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | Baseline (1 month), 6 months | 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. |
| Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) | Baseline (1 month), 6 months | 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. |
| Neurocognitive Assessments, Boston Naming Test | Baseline (1 month), 6 months | 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. |
| Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) | Baseline (1 month), 6 months | 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. |
| Neurocognitive Assessments, Trail Making A | Baseline (1 month), 6 months | 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. |
| Neurocognitive Assessments, Trail Making B | Baseline (1 month), 6 months | 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. |
| Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | Baseline (1 month), 6 months | 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 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HeartMate II Implantation of HeartMate II LVAS | 134 |
| HeartMate XVE Implantation of HeartMate XVE LVAS | 66 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Crossover | 0 | 2 |
| Overall Study | Not implanted | 1 | 5 |
Baseline characteristics
| Characteristic | HeartMate II | HeartMate XVE | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 12 | 62.5 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 24 Participants | 16 Participants | 40 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Other, unknown | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 101 Participants | 48 Participants | 149 Participants |
| Sex: Female, Male Female | 26 Participants | 5 Participants | 31 Participants |
| Sex: Female, Male Male | 108 Participants | 61 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 86 / 133 | 42 / 59 |
| serious Total, serious adverse events | 129 / 133 | 58 / 59 |
Outcome results
Primary
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
Population: Primary Study Cohort (Intent to Treat)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeartMate II | Composite Endpoint | 46 percentage of participants |
| HeartMate XVE | Composite Endpoint | 11 percentage of participants |
Comparison: Primary endpoint is 2-yr survival free of stroke or re-operation to repair/replace the device. Patients are a success if composite endpoint achieved. Patients urgently transplanted due to device failure are failures. Patients electively transplanted after reversal of co-morbidity will be considered success if they achieve 2 years of survival from day of VAD implant and no stroke. HMII is a success if the proportion of HMII pts achieving the composite endpoint is equal to or better than HM XVEp-value: 2.5e-795% CI: [24.5, 46.9]Fisher Exact
Secondary
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
Population: Primary Study Cohort (As Treated)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HeartMate II | Functional Status (Patient Activity Score) | Baseline (Moderate, High, Very High) | 5 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 3 Months (Very Low, Low) | 53 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | Baseline (Very Low, Low) | 95 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 3 Months (Moderate, High, Very High) | 47 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 1 Month (Very Low, Low) | 86 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 6 Months (Very Low, Low) | 45 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 12 Months (Very Low, Low) | 39 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 6 Months (Moderate, High, Very High) | 55 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 12 Months (Moderate, High, Very High) | 61 percentage of participants |
| HeartMate II | Functional Status (Patient Activity Score) | 1 Month (Moderate, High, Very High) | 14 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 12 Months (Moderate, High, Very High) | 38 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 12 Months (Very Low, Low) | 62 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | Baseline (Very Low, Low) | 94 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | Baseline (Moderate, High, Very High) | 6 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 1 Month (Very Low, Low) | 90 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 1 Month (Moderate, High, Very High) | 10 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 3 Months (Very Low, Low) | 58 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 3 Months (Moderate, High, Very High) | 42 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 6 Months (Very Low, Low) | 56 percentage of participants |
| HeartMate XVE | Functional Status (Patient Activity Score) | 6 Months (Moderate, High, Very High) | 44 percentage of participants |
Secondary
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
Population: Primary Study Cohort (As Treated)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate II | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 1 Month | 41.8 Units on a KCCQ score scale | Standard Deviation 20.3 |
| HeartMate II | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 6 Months | 64.2 Units on a KCCQ score scale | Standard Deviation 20.4 |
| HeartMate II | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 3 Months | 63.4 Units on a KCCQ score scale | Standard Deviation 18.5 |
| HeartMate II | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12 Months | 65.9 Units on a KCCQ score scale | Standard Deviation 20 |
| HeartMate II | Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline | 27.4 Units on a KCCQ score scale | Standard Deviation 16.3 |
| HeartMate XVE | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12 Months | 61.1 Units on a KCCQ score scale | Standard Deviation 20.4 |
| HeartMate XVE | Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline | 26.5 Units on a KCCQ score scale | Standard Deviation 17.4 |
| HeartMate XVE | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 1 Month | 38.9 Units on a KCCQ score scale | Standard Deviation 23.2 |
| HeartMate XVE | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 3 Months | 56.7 Units on a KCCQ score scale | Standard Deviation 21.1 |
| HeartMate XVE | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 6 Months | 55.5 Units on a KCCQ score scale | Standard Deviation 21.5 |
Secondary
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
Population: Primary Study Cohort (As Treated)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate II | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 1 Month | 62.8 Units on a MLWHF Score scale | Standard Deviation 23.7 |
| HeartMate II | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 6 Months | 36.5 Units on a MLWHF Score scale | Standard Deviation 23.3 |
| HeartMate II | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 3 Months | 37.4 Units on a MLWHF Score scale | Standard Deviation 22.2 |
| HeartMate II | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 12 Months | 33.6 Units on a MLWHF Score scale | Standard Deviation 22.1 |
| HeartMate II | Minnesota Living With Heart Failure Questionnaire(MLWHF) | Baseline | 75.2 Units on a MLWHF Score scale | Standard Deviation 17.7 |
| HeartMate XVE | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 12 Months | 41.2 Units on a MLWHF Score scale | Standard Deviation 21.4 |
| HeartMate XVE | Minnesota Living With Heart Failure Questionnaire(MLWHF) | Baseline | 76.3 Units on a MLWHF Score scale | Standard Deviation 18.1 |
| HeartMate XVE | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 1 Month | 59.1 Units on a MLWHF Score scale | Standard Deviation 26.5 |
| HeartMate XVE | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 3 Months | 43.6 Units on a MLWHF Score scale | Standard Deviation 23.8 |
| HeartMate XVE | Minnesota Living With Heart Failure Questionnaire(MLWHF) | 6 Months | 46.4 Units on a MLWHF Score scale | Standard Deviation 21 |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Neurocognitive Assessments, Boston Naming Test | Boston Naming, Baseline | 14.0 units on a scale |
| HeartMate II | Neurocognitive Assessments, Boston Naming Test | Boston Naming, 6 months | 14.0 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Boston Naming Test | Boston Naming, Baseline | 14.0 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Boston Naming Test | Boston Naming, 6 months | 13 units on a scale |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Neurocognitive Assessments, Clock Drawing | Clock drawing, baseline | 9.0 units on a scale |
| HeartMate II | Neurocognitive Assessments, Clock Drawing | Clock drawing, 6 months | 9 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Clock Drawing | Clock drawing, baseline | 8.5 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Clock Drawing | Clock drawing, 6 months | 9 units on a scale |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Neurocognitive Assessments, Trail Making A | Trail Making A, Baseline | 45.5 Units measured in seconds |
| HeartMate II | Neurocognitive Assessments, Trail Making A | Trail Making A, 6 months | 44.0 Units measured in seconds |
| HeartMate XVE | Neurocognitive Assessments, Trail Making A | Trail Making A, Baseline | 52.0 Units measured in seconds |
| HeartMate XVE | Neurocognitive Assessments, Trail Making A | Trail Making A, 6 months | 52 Units measured in seconds |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Neurocognitive Assessments, Trail Making B | Trail Making B, Baseline | 122.0 Units measured in seconds |
| HeartMate II | Neurocognitive Assessments, Trail Making B | Trail Making B, 6 months | 117.0 Units measured in seconds |
| HeartMate XVE | Neurocognitive Assessments, Trail Making B | Trail Making B, Baseline | 152.5 Units measured in seconds |
| HeartMate XVE | Neurocognitive Assessments, Trail Making B | Trail Making B, 6 months | 188.5 Units measured in seconds |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) | WAIS Block, Baseline | 29.0 units on a scale |
| HeartMate II | Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) | WAIS Block, 6 months | 31.0 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) | WAIS Block, Baseline | 25.5 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) | WAIS Block, 6 months | 28.0 units on a scale |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR, Baseline | 71.1 units on a scale |
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR, 6 months | 79 units on a scale |
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR Delayed, Baseline | 32 units on a scale |
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR Delayed, 6 months | 50.5 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR Delayed, 6 months | 38.0 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR, Baseline | 76.0 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR Delayed, Baseline | 37 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | WMS-VR, 6 months | 68 units on a scale |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM, 6 months | 24.0 units on a scale |
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM, Baseline | 19.5 units on a scale |
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM Delayed, Baseline | 16 units on a scale |
| HeartMate II | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM Delayed, 6 months | 18.5 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM Delayed, 6 months | 13 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM Delayed, Baseline | 12.5 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM, Baseline | 20.0 units on a scale |
| HeartMate XVE | Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | WMS-LM, 6 months | 14.0 units on a scale |
Secondary
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
Population: Primary Study Cohort (As Treated)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HeartMate II | New York Heart Association (NYHA) Classification | Baseline NYHA Class I - II | 0 percentage of participants in each class |
| HeartMate II | New York Heart Association (NYHA) Classification | Baseline NYHA Class III - IV | 100 percentage of participants in each class |
| HeartMate II | New York Heart Association (NYHA) Classification | 1 Month NYHA Class I - II | 45 percentage of participants in each class |
| HeartMate II | New York Heart Association (NYHA) Classification | 1 Month NYHA Class III - IV | 56 percentage of participants in each class |
| HeartMate II | New York Heart Association (NYHA) Classification | 6 months NYHA Class I - II | 79 percentage of participants in each class |
| HeartMate II | New York Heart Association (NYHA) Classification | 6 Months NYHA Class III - IV | 19 percentage of participants in each class |
| HeartMate II | New York Heart Association (NYHA) Classification | 12 Months NYHA Class I - II | 76 percentage of participants in each class |
| HeartMate II | New York Heart Association (NYHA) Classification | 12 Months NYHA Class III - IV | 24 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | 12 Months NYHA Class III - IV | 39 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | Baseline NYHA Class I - II | 0 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | 6 months NYHA Class I - II | 73 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | Baseline NYHA Class III - IV | 100 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | 12 Months NYHA Class I - II | 61 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | 1 Month NYHA Class I - II | 45 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | 6 Months NYHA Class III - IV | 27 percentage of participants in each class |
| HeartMate XVE | New York Heart Association (NYHA) Classification | 1 Month NYHA Class III - IV | 55 percentage of participants in each class |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HeartMate II | Reoperations | Pump Repair | 0 percentage of participants |
| HeartMate II | Reoperations | Other | 60.2 percentage of participants |
| HeartMate II | Reoperations | Pump Replacement | 9 percentage of participants |
| HeartMate II | Reoperations | Bleeding | 44.4 percentage of participants |
| HeartMate XVE | Reoperations | Other | 54.2 percentage of participants |
| HeartMate XVE | Reoperations | Pump Repair | 1.7 percentage of participants |
| HeartMate XVE | Reoperations | Bleeding | 23.7 percentage of participants |
| HeartMate XVE | Reoperations | Pump Replacement | 32 percentage of participants |
Secondary
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.
Time frame: Baseline, Months 1, 3, 6, 12
Population: Primary Study Cohort (As Treated)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeartMate II | Six Minute Walk Test (6MWT) | Baseline | 182.5 Distance (meters) | Standard Deviation 140.6 |
| HeartMate II | Six Minute Walk Test (6MWT) | 6 Months | 377.2 Distance (meters) | Standard Deviation 252.7 |
| HeartMate II | Six Minute Walk Test (6MWT) | 3 Months | 316.5 Distance (meters) | Standard Deviation 191 |
| HeartMate II | Six Minute Walk Test (6MWT) | 12 Months | 317.6 Distance (meters) | Standard Deviation 163.6 |
| HeartMate II | Six Minute Walk Test (6MWT) | 1 Month | 244.2 Distance (meters) | Standard Deviation 179.2 |
| HeartMate XVE | Six Minute Walk Test (6MWT) | 12 Months | 307.6 Distance (meters) | Standard Deviation 144.9 |
| HeartMate XVE | Six Minute Walk Test (6MWT) | Baseline | 172.2 Distance (meters) | Standard Deviation 107.7 |
| HeartMate XVE | Six Minute Walk Test (6MWT) | 3 Months | 291.0 Distance (meters) | Standard Deviation 136.5 |
| HeartMate XVE | Six Minute Walk Test (6MWT) | 6 Months | 339.7 Distance (meters) | Standard Deviation 134.4 |
| HeartMate XVE | Six Minute Walk Test (6MWT) | 1 Month | 236.0 Distance (meters) | Standard Deviation 134.1 |
Secondary
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
Population: Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HeartMate II | Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) | WAIS Digit, Baseline | 45 units on a scale |
| HeartMate II | Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) | WAIS Digit, 6 months | 45 units on a scale |
| HeartMate XVE | Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) | WAIS Digit, Baseline | 31 units on a scale |
| HeartMate XVE | Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) | WAIS Digit, 6 months | 34 units on a scale |