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

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ClinicalTrials.gov Identifier: NCT00121485
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : October 29, 2013
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Corporation )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Failure, Congestive
Ventricular Dysfunction
Cardiomyopathies
Intervention Device: Left Ventricular Assist System (LVAS)
Enrollment 200

Recruitment Details  
Pre-assignment Details  
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description Implantation of HeartMate II LVAS Implantation of HeartMate XVE LVAS
Period Title: Overall Study
Started 134 66
Completed 133 59
Not Completed 1 7
Reason Not Completed
Not implanted             1             5
Crossover             0             2
Arm/Group Title HeartMate II HeartMate XVE Total
Hide Arm/Group Description Implantation of HeartMate II LVAS Implantation of HeartMate XVE LVAS Total of all reporting groups
Overall Number of Baseline Participants 134 66 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 66 participants 200 participants
62  (12) 63  (12) 62.5  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 66 participants 200 participants
Female
26
  19.4%
5
   7.6%
31
  15.5%
Male
108
  80.6%
61
  92.4%
169
  84.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 134 participants 66 participants 200 participants
Asian 2 0 2
Hispanic 4 0 4
Black or African American 24 16 40
White 101 48 149
Other, unknown 3 2 5
1.Primary Outcome
Title Composite Endpoint
Hide Description 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
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Hide Analysis Population Description
Primary Study Cohort (Intent to Treat)
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE LVAS
Overall Number of Participants Analyzed 134 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46
(38 to 55)
11
(3 to 18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HeartMate II, HeartMate XVE
Comments 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 XVE
Type of Statistical Test Non-Inferiority or Equivalence
Comments 200 patients (137 HMII and 67 XVE) provides 80% power (alpha= 0.05 (one-sided)) using a Blackwelder like analysis and a non-inferiority margin of 10%. The protocol specifies that once non-inferiority is proven, the data will be analyzed for superiority using closed testing methods.
Statistical Test of Hypothesis P-Value 0.00000025
Comments Two (2) interim analysis were pre-specified in the protocol. The type I error rate was preserved at 5% by use of the O’Brien-Fleming spending function.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 35.7
Confidence Interval (2-Sided) 95%
24.5 to 46.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Minnesota Living With Heart Failure Questionnaire(MLWHF)
Hide Description 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
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Hide Analysis Population Description
Primary Study Cohort (As Treated)
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE LVAS
Overall Number of Participants Analyzed 133 59
Mean (Standard Deviation)
Unit of Measure: Units on a MLWHF Score scale
Baseline 75.2  (17.7) 76.3  (18.1)
1 Month 62.8  (23.7) 59.1  (26.5)
3 Months 37.4  (22.2) 43.6  (23.8)
6 Months 36.5  (23.3) 46.4  (21.0)
12 Months 33.6  (22.1) 41.2  (21.4)
3.Secondary Outcome
Title Kansas City Cardiomyopathy Questionnaire (KCCQ)
Hide Description 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
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Hide Analysis Population Description
Primary Study Cohort (As Treated)
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE LVAS
Overall Number of Participants Analyzed 133 59
Mean (Standard Deviation)
Unit of Measure: Units on a KCCQ score scale
Baseline 27.4  (16.3) 26.5  (17.4)
1 Month 41.8  (20.3) 38.9  (23.2)
3 Months 63.4  (18.5) 56.7  (21.1)
6 Months 64.2  (20.4) 55.5  (21.5)
12 Months 65.9  (20.0) 61.1  (20.4)
4.Secondary Outcome
Title New York Heart Association (NYHA) Classification
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary Study Cohort (As Treated)
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE LVAS
Overall Number of Participants Analyzed 133 59
Measure Type: Number
Unit of Measure: percentage of participants in each class
Baseline NYHA Class I - II 0 0
Baseline NYHA Class III - IV 100 100
1 Month NYHA Class I - II 45 45
1 Month NYHA Class III - IV 56 55
6 months NYHA Class I - II 79 73
6 Months NYHA Class III - IV 19 27
12 Months NYHA Class I - II 76 61
12 Months NYHA Class III - IV 24 39
5.Secondary Outcome
Title Six Minute Walk Test (6MWT)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary Study Cohort (As Treated)
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE LVAS
Overall Number of Participants Analyzed 133 59
Mean (Standard Deviation)
Unit of Measure: Distance (meters)
Baseline 182.5  (140.6) 172.2  (107.7)
1 Month 244.2  (179.2) 236.0  (134.1)
3 Months 316.5  (191) 291.0  (136.5)
6 Months 377.2  (252.7) 339.7  (134.4)
12 Months 317.6  (163.6) 307.6  (144.9)
6.Secondary Outcome
Title Functional Status (Patient Activity Score)
Hide Description Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
Time Frame Baseline, Months 1, 3, 6, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary Study Cohort (As Treated)
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE LVAS
Overall Number of Participants Analyzed 133 59
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (Very Low, Low) 95 94
Baseline (Moderate, High, Very High) 5 6
1 Month (Very Low, Low) 86 90
1 Month (Moderate, High, Very High) 14 10
3 Months (Very Low, Low) 53 58
3 Months (Moderate, High, Very High) 47 42
6 Months (Very Low, Low) 45 56
6 Months (Moderate, High, Very High) 55 44
12 Months (Very Low, Low) 39 62
12 Months (Moderate, High, Very High) 61 38
7.Secondary Outcome
Title Reoperations
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE LVAS
Overall Number of Participants Analyzed 133 59
Measure Type: Number
Unit of Measure: percentage of participants
Pump Replacement 9 32
Pump Repair 0 1.7
Bleeding 44.4 23.7
Other 60.2 54.2
8.Secondary Outcome
Title Neurocognitive Assessments, Clock Drawing
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 44 16
Median (Full Range)
Unit of Measure: units on a scale
Clock drawing, baseline
9.0
(4 to 10)
8.5
(4 to 10)
Clock drawing, 6 months
9
(4 to 10)
9
(4 to 10)
9.Secondary Outcome
Title Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 46 16
Median (Full Range)
Unit of Measure: units on a scale
WMS-LM, Baseline
19.5
(4 to 32)
20.0
(3 to 33)
WMS-LM, 6 months
24.0
(5 to 45)
14.0
(5 to 29)
WMS-LM Delayed, Baseline
16
(4 to 28)
12.5
(1 to 31)
WMS-LM Delayed, 6 months
18.5
(1 to 36)
13
(1 to 27)
10.Secondary Outcome
Title Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 44 16
Median (Full Range)
Unit of Measure: units on a scale
WMS-VR, Baseline
71.1
(13 to 102)
76.0
(21 to 101)
WMS-VR, 6 months
79
(27 to 104)
68
(5 to 100)
WMS-VR Delayed, Baseline
32
(2 to 90)
37
(6 to 98)
WMS-VR Delayed, 6 months
50.5
(8 to 93)
38.0
(4 to 97)
11.Secondary Outcome
Title Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 43 16
Median (Full Range)
Unit of Measure: units on a scale
WAIS Block, Baseline
29.0
(12 to 50)
25.5
(5 to 50)
WAIS Block, 6 months
31.0
(10 to 64)
28.0
(12 to 44)
12.Secondary Outcome
Title Neurocognitive Assessments, Boston Naming Test
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 45 16
Median (Full Range)
Unit of Measure: units on a scale
Boston Naming, Baseline
14.0
(4 to 15)
14.0
(9 to 15)
Boston Naming, 6 months
14.0
(6 to 15)
13
(10 to 15)
13.Secondary Outcome
Title Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 43 15
Median (Full Range)
Unit of Measure: units on a scale
WAIS Digit, Baseline
45
(9 to 89)
31
(4 to 85)
WAIS Digit, 6 months
45
(13 to 84)
34
(10 to 73)
14.Secondary Outcome
Title Neurocognitive Assessments, Trail Making A
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 42 14
Median (Full Range)
Unit of Measure: Units measured in seconds
Trail Making A, Baseline
45.5
(23 to 148)
52.0
(19 to 119)
Trail Making A, 6 months
44.0
(16 to 77)
52
(25 to 130)
15.Secondary Outcome
Title Neurocognitive Assessments, Trail Making B
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description:
Implantation of HeartMate II LVAS
Implantation of HeartMate XVE
Overall Number of Participants Analyzed 41 14
Median (Full Range)
Unit of Measure: Units measured in seconds
Trail Making B, Baseline
122.0
(30 to 495)
152.5
(43 to 403)
Trail Making B, 6 months
117.0
(33 to 423)
188.5
(55 to 420)
Time Frame Patients were followed until outcome (transplanted, explanted, expired, withdrawn), for an average of 1.2 years
Adverse Event Reporting Description All serious adverse events for duration of study are listed below
 
Arm/Group Title HeartMate II HeartMate XVE
Hide Arm/Group Description Implantation of HeartMate II LVAS Implantation of HeartMate XVE LVAS
All-Cause Mortality
HeartMate II HeartMate XVE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HeartMate II HeartMate XVE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   129/133 (96.99%)      58/59 (98.31%)    
Blood and lymphatic system disorders     
Bleeding (All serious events)  [1]  102/133 (76.69%)  278 41/59 (69.49%)  70
Device Thrombosis  [2]  5/133 (3.76%)  5 0/59 (0.00%)  0
Hemolysis  [3]  5/133 (3.76%)  5 0/59 (0.00%)  0
Cardiac disorders     
Right Heart Failure (Inotropes)  [4]  27/133 (20.30%)  29 16/59 (27.12%)  19
Right Heart Failure (RVAD)  [5]  5/133 (3.76%)  5 3/59 (5.08%)  3
Cardiac Arrhythmia  [6]  62/133 (46.62%)  110 21/59 (35.59%)  30
Myocardial Infarction   0/133 (0.00%)  0 1/59 (1.69%)  1
Confirmed Malfunctions   30/133 (22.56%)  39 12/59 (20.34%)  14
Hepatobiliary disorders     
Hepatic Dysfunction  [7]  3/133 (2.26%)  3 0/59 (0.00%)  0
Infections and infestations     
Local Infection  [8]  40/133 (30.08%)  60 19/59 (32.20%)  30
Drive Line Infection  [9]  39/133 (29.32%)  75 14/59 (23.73%)  22
Pocket Infection  [10]  12/133 (9.02%)  19 8/59 (13.56%)  10
Pump Housing  [11]  1/133 (0.75%)  1 2/59 (3.39%)  2
Sepsis  [12]  48/133 (36.09%)  80 26/59 (44.07%)  45
Nervous system disorders     
Stroke  [13]  24/133 (18.05%)  27 8/59 (13.56%)  9
Other neurological  [14]  27/133 (20.30%)  32 9/59 (15.25%)  11
Psychiatric disorders     
Psychological  [15]  4/133 (3.01%)  4 0/59 (0.00%)  0
Renal and urinary disorders     
Renal Failure  [16]  21/133 (15.79%)  21 14/59 (23.73%)  14
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure  [17]  47/133 (35.34%)  61 24/59 (40.68%)  33
Surgical and medical procedures     
Bleeding requiring surgery   40/133 (30.08%)  50 9/59 (15.25%)  12
Vascular disorders     
Peripheral Thromboembolism  [18]  14/133 (10.53%)  21 6/59 (10.17%)  6
Indicates events were collected by systematic assessment
[1]
events that cause death, reoperations, permanent injury or necessitate transfusion of >2 units of PRBC within 24 hours
[2]
thrombus in device or conduits with symptoms of impaired pump performance (e.g. decreased pump flow, need increase speed, increased power, hemolysis) or need for thrombolytic or surgical intervention
[3]
two consecutive PHgb values above 40 mg/dl and a LDH value above 1,000mg/dl during the same time
[4]
Need for inotropic support for > 14 days after implant
[5]
the need for RVAD
[6]
any arrhythmia that requires intervention
[7]
liver function studies that are greater than three times the baseline values in any two of the three liver function studies (total bilirubin, AST and ALT)
[8]
Localized non-device related infections
[9]
infection of the drive line
[10]
Infection of the pump pocket
[11]
Infection of the pump housing
[12]
a systemic response to a serious infection, usually manifested by fever, tachycardia, tachypnea, leukocytosis and vasodilatation requiring use of IV antimicrobial therapy
[13]
neurological deficit lasting more than 24 hours or lasting 24 hours or less with a brain imaging study showing new infarction
[14]
any new, temporary or permanent, focal or global neurological deficit including TIA, metabolic encephalopathy, seizure, etc
[15]
disturbance in thinking, emotion or behavior that causes substantial impairment in functioning or marked subjective distress requiring intervention
[16]
require renal replacement therapy (CVVHD or dialysis) that was not required prior to implant
[17]
Impairment of respiratory function requiring reintubation and/or tracheostomy at any time or the inability to discontinue ventilatory support after 6 days of VAD support
[18]
Any thrombus or thrombo-embolism in the pulmonary or systemic circulations confirmed by standard clinical and laboratory testing, or operative findings, or autopsy findings, or that requires empirical intervention
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HeartMate II HeartMate XVE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   86/133 (64.66%)      42/59 (71.19%)    
Blood and lymphatic system disorders     
Bleeding   16/133 (12.03%)  121 10/59 (16.95%)  43
Cardiac disorders     
Cardiac Arrhythmia   13/133 (9.77%)  35 14/59 (23.73%)  24
Confirmed Malfunctions   28/133 (21.05%)  73 6/59 (10.17%)  13
Infections and infestations     
Local Infection   25/133 (18.80%)  100 8/59 (13.56%)  25
Psychiatric disorders     
Psychological   4/133 (3.01%)  7 4/59 (6.78%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Poornima Sood, MD, MBA, Sr. Director, Clinical Affairs
Organization: Thoratec Corporation
Phone: 781 852 8334
Responsible Party: St. Jude Medical ( Thoratec Corporation )
ClinicalTrials.gov Identifier: NCT00121485     History of Changes
Other Study ID Numbers: TC010230-2
First Submitted: July 12, 2005
First Posted: July 21, 2005
Results First Submitted: November 13, 2012
Results First Posted: October 29, 2013
Last Update Posted: April 12, 2016