Trial Outcomes & Findings for Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy (NCT NCT00121485)
NCT ID: NCT00121485
Last Updated: 2022-06-27
Results Overview
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Patients' status at 2 years post-implant
Results posted on
2022-06-27
Participant Flow
Participant milestones
| Measure |
HeartMate II
Implantation of HeartMate II LVAS
|
HeartMate XVE
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
66
|
|
Overall Study
COMPLETED
|
133
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
| Measure |
HeartMate II
Implantation of HeartMate II LVAS
|
HeartMate XVE
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Overall Study
Not implanted
|
1
|
5
|
|
Overall Study
Crossover
|
0
|
2
|
Baseline Characteristics
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
Baseline characteristics by cohort
| Measure |
HeartMate II
n=134 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=66 Participants
Implantation of HeartMate XVE LVAS
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 12 • n=5 Participants
|
63 years
STANDARD_DEVIATION 12 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients' status at 2 years post-implantPopulation: Primary Study Cohort (Intent to Treat)
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Outcome measures
| Measure |
HeartMate II
n=134 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=66 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Composite Endpoint
|
46 percentage of participants
Interval 38.0 to 55.0
|
11 percentage of participants
Interval 3.0 to 18.0
|
SECONDARY outcome
Timeframe: Baseline, Months 1,3,6,12Population: Primary Study Cohort (As Treated)
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.
Outcome measures
| Measure |
HeartMate II
n=133 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Minnesota Living With Heart Failure Questionnaire(MLWHF)
Baseline
|
75.2 Units on a MLWHF Score scale
Standard Deviation 17.7
|
76.3 Units on a MLWHF Score scale
Standard Deviation 18.1
|
|
Minnesota Living With Heart Failure Questionnaire(MLWHF)
1 Month
|
62.8 Units on a MLWHF Score scale
Standard Deviation 23.7
|
59.1 Units on a MLWHF Score scale
Standard Deviation 26.5
|
|
Minnesota Living With Heart Failure Questionnaire(MLWHF)
3 Months
|
37.4 Units on a MLWHF Score scale
Standard Deviation 22.2
|
43.6 Units on a MLWHF Score scale
Standard Deviation 23.8
|
|
Minnesota Living With Heart Failure Questionnaire(MLWHF)
6 Months
|
36.5 Units on a MLWHF Score scale
Standard Deviation 23.3
|
46.4 Units on a MLWHF Score scale
Standard Deviation 21.0
|
|
Minnesota Living With Heart Failure Questionnaire(MLWHF)
12 Months
|
33.6 Units on a MLWHF Score scale
Standard Deviation 22.1
|
41.2 Units on a MLWHF Score scale
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12Population: Primary Study Cohort (As Treated)
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.
Outcome measures
| Measure |
HeartMate II
n=133 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Baseline
|
27.4 Units on a KCCQ score scale
Standard Deviation 16.3
|
26.5 Units on a KCCQ score scale
Standard Deviation 17.4
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
1 Month
|
41.8 Units on a KCCQ score scale
Standard Deviation 20.3
|
38.9 Units on a KCCQ score scale
Standard Deviation 23.2
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
3 Months
|
63.4 Units on a KCCQ score scale
Standard Deviation 18.5
|
56.7 Units on a KCCQ score scale
Standard Deviation 21.1
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
6 Months
|
64.2 Units on a KCCQ score scale
Standard Deviation 20.4
|
55.5 Units on a KCCQ score scale
Standard Deviation 21.5
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
12 Months
|
65.9 Units on a KCCQ score scale
Standard Deviation 20.0
|
61.1 Units on a KCCQ score scale
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 6, 12Population: Primary Study Cohort (As Treated)
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
Outcome measures
| Measure |
HeartMate II
n=133 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
New York Heart Association (NYHA) Classification
Baseline NYHA Class I - II
|
0 percentage of participants in each class
|
0 percentage of participants in each class
|
|
New York Heart Association (NYHA) Classification
Baseline NYHA Class III - IV
|
100 percentage of participants in each class
|
100 percentage of participants in each class
|
|
New York Heart Association (NYHA) Classification
1 Month NYHA Class I - II
|
45 percentage of participants in each class
|
45 percentage of participants in each class
|
|
New York Heart Association (NYHA) Classification
1 Month NYHA Class III - IV
|
56 percentage of participants in each class
|
55 percentage of participants in each class
|
|
New York Heart Association (NYHA) Classification
6 months NYHA Class I - II
|
79 percentage of participants in each class
|
73 percentage of participants in each class
|
|
New York Heart Association (NYHA) Classification
6 Months NYHA Class III - IV
|
19 percentage of participants in each class
|
27 percentage of participants in each class
|
|
New York Heart Association (NYHA) Classification
12 Months NYHA Class I - II
|
76 percentage of participants in each class
|
61 percentage of participants in each class
|
|
New York Heart Association (NYHA) Classification
12 Months NYHA Class III - IV
|
24 percentage of participants in each class
|
39 percentage of participants in each class
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12Population: Primary Study Cohort (As Treated)
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.
Outcome measures
| Measure |
HeartMate II
n=133 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Six Minute Walk Test (6MWT)
Baseline
|
182.5 Distance (meters)
Standard Deviation 140.6
|
172.2 Distance (meters)
Standard Deviation 107.7
|
|
Six Minute Walk Test (6MWT)
1 Month
|
244.2 Distance (meters)
Standard Deviation 179.2
|
236.0 Distance (meters)
Standard Deviation 134.1
|
|
Six Minute Walk Test (6MWT)
3 Months
|
316.5 Distance (meters)
Standard Deviation 191
|
291.0 Distance (meters)
Standard Deviation 136.5
|
|
Six Minute Walk Test (6MWT)
6 Months
|
377.2 Distance (meters)
Standard Deviation 252.7
|
339.7 Distance (meters)
Standard Deviation 134.4
|
|
Six Minute Walk Test (6MWT)
12 Months
|
317.6 Distance (meters)
Standard Deviation 163.6
|
307.6 Distance (meters)
Standard Deviation 144.9
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12Population: Primary Study Cohort (As Treated)
Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
Outcome measures
| Measure |
HeartMate II
n=133 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Functional Status (Patient Activity Score)
Baseline (Very Low, Low)
|
95 percentage of participants
|
94 percentage of participants
|
|
Functional Status (Patient Activity Score)
Baseline (Moderate, High, Very High)
|
5 percentage of participants
|
6 percentage of participants
|
|
Functional Status (Patient Activity Score)
1 Month (Very Low, Low)
|
86 percentage of participants
|
90 percentage of participants
|
|
Functional Status (Patient Activity Score)
1 Month (Moderate, High, Very High)
|
14 percentage of participants
|
10 percentage of participants
|
|
Functional Status (Patient Activity Score)
3 Months (Very Low, Low)
|
53 percentage of participants
|
58 percentage of participants
|
|
Functional Status (Patient Activity Score)
3 Months (Moderate, High, Very High)
|
47 percentage of participants
|
42 percentage of participants
|
|
Functional Status (Patient Activity Score)
6 Months (Very Low, Low)
|
45 percentage of participants
|
56 percentage of participants
|
|
Functional Status (Patient Activity Score)
6 Months (Moderate, High, Very High)
|
55 percentage of participants
|
44 percentage of participants
|
|
Functional Status (Patient Activity Score)
12 Months (Very Low, Low)
|
39 percentage of participants
|
62 percentage of participants
|
|
Functional Status (Patient Activity Score)
12 Months (Moderate, High, Very High)
|
61 percentage of participants
|
38 percentage of participants
|
SECONDARY outcome
Timeframe: Patients were followed until outcome or up to 2 years post-implant, whichever came firstThe 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
Outcome measures
| Measure |
HeartMate II
n=133 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Reoperations
Pump Replacement
|
9 percentage of participants
|
32 percentage of participants
|
|
Reoperations
Pump Repair
|
0 percentage of participants
|
1.7 percentage of participants
|
|
Reoperations
Bleeding
|
44.4 percentage of participants
|
23.7 percentage of participants
|
|
Reoperations
Other
|
60.2 percentage of participants
|
54.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HeartMate II
n=44 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=16 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Neurocognitive Assessments, Clock Drawing
Clock drawing, baseline
|
9.0 units on a scale
Interval 4.0 to 10.0
|
8.5 units on a scale
Interval 4.0 to 10.0
|
|
Neurocognitive Assessments, Clock Drawing
Clock drawing, 6 months
|
9 units on a scale
Interval 4.0 to 10.0
|
9 units on a scale
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
HeartMate II
n=46 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=16 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
WMS-LM, Baseline
|
19.5 units on a scale
Interval 4.0 to 32.0
|
20.0 units on a scale
Interval 3.0 to 33.0
|
|
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
WMS-LM, 6 months
|
24.0 units on a scale
Interval 5.0 to 45.0
|
14.0 units on a scale
Interval 5.0 to 29.0
|
|
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
WMS-LM Delayed, Baseline
|
16 units on a scale
Interval 4.0 to 28.0
|
12.5 units on a scale
Interval 1.0 to 31.0
|
|
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
WMS-LM Delayed, 6 months
|
18.5 units on a scale
Interval 1.0 to 36.0
|
13 units on a scale
Interval 1.0 to 27.0
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HeartMate II
n=44 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=16 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
WMS-VR, Baseline
|
71.1 units on a scale
Interval 13.0 to 102.0
|
76.0 units on a scale
Interval 21.0 to 101.0
|
|
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
WMS-VR, 6 months
|
79 units on a scale
Interval 27.0 to 104.0
|
68 units on a scale
Interval 5.0 to 100.0
|
|
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
WMS-VR Delayed, Baseline
|
32 units on a scale
Interval 2.0 to 90.0
|
37 units on a scale
Interval 6.0 to 98.0
|
|
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
Interval 8.0 to 93.0
|
38.0 units on a scale
Interval 4.0 to 97.0
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HeartMate II
n=43 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=16 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
WAIS Block, Baseline
|
29.0 units on a scale
Interval 12.0 to 50.0
|
25.5 units on a scale
Interval 5.0 to 50.0
|
|
Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
WAIS Block, 6 months
|
31.0 units on a scale
Interval 10.0 to 64.0
|
28.0 units on a scale
Interval 12.0 to 44.0
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HeartMate II
n=45 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=16 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Neurocognitive Assessments, Boston Naming Test
Boston Naming, Baseline
|
14.0 units on a scale
Interval 4.0 to 15.0
|
14.0 units on a scale
Interval 9.0 to 15.0
|
|
Neurocognitive Assessments, Boston Naming Test
Boston Naming, 6 months
|
14.0 units on a scale
Interval 6.0 to 15.0
|
13 units on a scale
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HeartMate II
n=43 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=15 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
WAIS Digit, Baseline
|
45 units on a scale
Interval 9.0 to 89.0
|
31 units on a scale
Interval 4.0 to 85.0
|
|
Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
WAIS Digit, 6 months
|
45 units on a scale
Interval 13.0 to 84.0
|
34 units on a scale
Interval 10.0 to 73.0
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HeartMate II
n=42 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=14 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Neurocognitive Assessments, Trail Making A
Trail Making A, Baseline
|
45.5 Units measured in seconds
Interval 23.0 to 148.0
|
52.0 Units measured in seconds
Interval 19.0 to 119.0
|
|
Neurocognitive Assessments, Trail Making A
Trail Making A, 6 months
|
44.0 Units measured in seconds
Interval 16.0 to 77.0
|
52 Units measured in seconds
Interval 25.0 to 130.0
|
SECONDARY outcome
Timeframe: Baseline (1 month), 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
HeartMate II
n=41 Participants
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=14 Participants
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Neurocognitive Assessments, Trail Making B
Trail Making B, Baseline
|
122.0 Units measured in seconds
Interval 30.0 to 495.0
|
152.5 Units measured in seconds
Interval 43.0 to 403.0
|
|
Neurocognitive Assessments, Trail Making B
Trail Making B, 6 months
|
117.0 Units measured in seconds
Interval 33.0 to 423.0
|
188.5 Units measured in seconds
Interval 55.0 to 420.0
|
Adverse Events
HeartMate II
Serious events: 129 serious events
Other events: 86 other events
Deaths: 0 deaths
HeartMate XVE
Serious events: 58 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HeartMate II
n=133 participants at risk
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 participants at risk
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding (All serious events)
|
76.7%
102/133 • Number of events 278 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
69.5%
41/59 • Number of events 70 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Surgical and medical procedures
Bleeding requiring surgery
|
30.1%
40/133 • Number of events 50 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
15.3%
9/59 • Number of events 12 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Nervous system disorders
Stroke
|
18.0%
24/133 • Number of events 27 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
13.6%
8/59 • Number of events 9 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Nervous system disorders
Other neurological
|
20.3%
27/133 • Number of events 32 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
15.3%
9/59 • Number of events 11 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Infections and infestations
Local Infection
|
30.1%
40/133 • Number of events 60 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
32.2%
19/59 • Number of events 30 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Infections and infestations
Drive Line Infection
|
29.3%
39/133 • Number of events 75 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
23.7%
14/59 • Number of events 22 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Infections and infestations
Pocket Infection
|
9.0%
12/133 • Number of events 19 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
13.6%
8/59 • Number of events 10 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Infections and infestations
Pump Housing
|
0.75%
1/133 • Number of events 1 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
3.4%
2/59 • Number of events 2 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Infections and infestations
Sepsis
|
36.1%
48/133 • Number of events 80 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
44.1%
26/59 • Number of events 45 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Cardiac disorders
Right Heart Failure (Inotropes)
|
20.3%
27/133 • Number of events 29 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
27.1%
16/59 • Number of events 19 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Cardiac disorders
Right Heart Failure (RVAD)
|
3.8%
5/133 • Number of events 5 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
5.1%
3/59 • Number of events 3 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Vascular disorders
Peripheral Thromboembolism
|
10.5%
14/133 • Number of events 21 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
10.2%
6/59 • Number of events 6 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
35.3%
47/133 • Number of events 61 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
40.7%
24/59 • Number of events 33 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Cardiac disorders
Cardiac Arrhythmia
|
46.6%
62/133 • Number of events 110 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
35.6%
21/59 • Number of events 30 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Renal and urinary disorders
Renal Failure
|
15.8%
21/133 • Number of events 21 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
23.7%
14/59 • Number of events 14 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
2.3%
3/133 • Number of events 3 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
0.00%
0/59 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Blood and lymphatic system disorders
Device Thrombosis
|
3.8%
5/133 • Number of events 5 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
0.00%
0/59 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.8%
5/133 • Number of events 5 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
0.00%
0/59 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Psychiatric disorders
Psychological
|
3.0%
4/133 • Number of events 4 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
0.00%
0/59 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/133 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
1.7%
1/59 • Number of events 1 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Cardiac disorders
Confirmed Malfunctions
|
22.6%
30/133 • Number of events 39 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
20.3%
12/59 • Number of events 14 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
Other adverse events
| Measure |
HeartMate II
n=133 participants at risk
Implantation of HeartMate II LVAS
|
HeartMate XVE
n=59 participants at risk
Implantation of HeartMate XVE LVAS
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
12.0%
16/133 • Number of events 121 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
16.9%
10/59 • Number of events 43 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Infections and infestations
Local Infection
|
18.8%
25/133 • Number of events 100 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
13.6%
8/59 • Number of events 25 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Cardiac disorders
Cardiac Arrhythmia
|
9.8%
13/133 • Number of events 35 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
23.7%
14/59 • Number of events 24 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Psychiatric disorders
Psychological
|
3.0%
4/133 • Number of events 7 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
6.8%
4/59 • Number of events 4 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
|
Cardiac disorders
Confirmed Malfunctions
|
21.1%
28/133 • Number of events 73 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
10.2%
6/59 • Number of events 13 • Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
All serious adverse events for duration of study are listed below
|
Additional Information
Poornima Sood, MD, MBA, Sr. Director, Clinical Affairs
Thoratec Corporation
Phone: 781 852 8334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place