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| Name | Class |
|---|---|
| Thoratec Corporation | INDUSTRY |
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The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.
The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartMate II | Experimental | Implantation of HeartMate II LVAS |
|
| HeartMate XVE | Active Comparator | Implantation of HeartMate XVE LVAS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Ventricular Assist System (LVAS) | Device | Implantation of left ventricular assist device for hemodynamic support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint | Survival at two (2) years free of stroke, or reoperation to repair or replace the device | Patients' status at 2 years post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Living With Heart Failure Questionnaire(MLWHF) | MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life. |
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Inclusion Criteria:
The following are general criteria; more specific conditions are included in the study protocol:
Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Chatterjee | Thoratec Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Mayo Clinic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19920051 | Result | Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17. | |
| 22153550 |
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| ID | Title | Description |
|---|---|---|
| FG000 | HeartMate II | Implantation of HeartMate II LVAS |
| FG001 | HeartMate XVE | Implantation of HeartMate XVE LVAS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, Months 1,3,6,12 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life. | Baseline, Months 1, 3, 6, 12 |
| New York Heart Association (NYHA) Classification | NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort | Baseline, Months 1, 6, 12 |
| Six Minute Walk Test (6MWT) | The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status. | Baseline, Months 1, 3, 6, 12 |
| Functional Status (Patient Activity Score) | Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High | Baseline, Months 1, 3, 6, 12 |
| Reoperations | The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons | Patients were followed until outcome or up to 2 years post-implant, whichever came first |
| Neurocognitive Assessments, Clock Drawing | Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score. | Baseline (1 month), 6 months |
| Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) | The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better | Baseline (1 month), 6 months |
| Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) | The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better. | Baseline (1 month), 6 months |
| Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) | The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better. | Baseline (1 month), 6 months |
| Neurocognitive Assessments, Boston Naming Test | Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better. | Baseline (1 month), 6 months |
| Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) | The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better. | Baseline (1 month), 6 months |
| Neurocognitive Assessments, Trail Making A | This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better. | Baseline (1 month), 6 months |
| Neurocognitive Assessments, Trail Making B | This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better. | Baseline (1 month), 6 months |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of Colorado Hospital | Denver | Colorado | 80262 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Shands Hospital @ University of Florida | Gainesville | Florida | 32610 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Methodist Hospital | Indianapolis | Indiana | 46206 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Tufts / New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Barnes-Jewish Hospital/Washington University | St Louis | Missouri | 63110 | United States |
| Bryan LGH Heart Institute | Lincoln | Nebraska | 68516 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| New York Columbia Presbyterian Medical Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43212 | United States |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Milton Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
| Hospital of University of PA | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Medical City Hospital Dallas | Dallas | Texas | 75230 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| LDS Hospital (Intermountain Health Care) | Salt Lake City | Utah | 84143 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23510 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| University of Wisconsin Medical School | Madison | Wisconsin | 53792 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Hospital Royal Victoria / McGill University Health Centre | Montreal | Quebec | H3A 1A1 | Canada |
| Petrucci RJ, Rogers JG, Blue L, Gallagher C, Russell SD, Dordunoo D, Jaski BE, Chillcott S, Sun B, Yanssens TL, Tatooles A, Koundakjian L, Farrar DJ, Slaughter MS. Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsatile-flow left ventricular assist device support. J Heart Lung Transplant. 2012 Jan;31(1):27-36. doi: 10.1016/j.healun.2011.10.012. |
| 22282104 | Result | Park SJ, Milano CA, Tatooles AJ, Rogers JG, Adamson RM, Steidley DE, Ewald GA, Sundareswaran KS, Farrar DJ, Slaughter MS; HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012 Mar 1;5(2):241-8. doi: 10.1161/CIRCHEARTFAILURE.111.963991. Epub 2012 Jan 26. |
| 24750460 | Derived | Brisco MA, Sundareswaran KS, Milano CA, Feldman D, Testani JM, Ewald GA, Slaughter MS, Farrar DJ, Goldberg LR; HeartMate II Clinical Investigators. Incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices. J Card Surg. 2014 Jul;29(4):572-80. doi: 10.1111/jocs.12336. Epub 2014 Apr 18. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HeartMate II | Implantation of HeartMate II LVAS |
| BG001 | HeartMate XVE | Implantation of HeartMate XVE LVAS |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Endpoint | Survival at two (2) years free of stroke, or reoperation to repair or replace the device | Primary Study Cohort (Intent to Treat) | Posted | Number | 95% Confidence Interval | percentage of participants | Patients' status at 2 years post-implant |
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| 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. | Primary Study Cohort (As Treated) | Posted | Mean | Standard Deviation | Units on a MLWHF Score scale | Baseline, Months 1,3,6,12 |
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| 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. | Primary Study Cohort (As Treated) | Posted | Mean | Standard Deviation | Units on a KCCQ score scale | Baseline, Months 1, 3, 6, 12 |
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| 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 | Primary Study Cohort (As Treated) | Posted | Number | percentage of participants in each class | Baseline, Months 1, 6, 12 |
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| 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. | Primary Study Cohort (As Treated) | Posted | Mean | Standard Deviation | Distance (meters) | Baseline, Months 1, 3, 6, 12 |
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| Secondary | Functional Status (Patient Activity Score) | Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High | Primary Study Cohort (As Treated) | Posted | Number | percentage of participants | Baseline, Months 1, 3, 6, 12 |
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| 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 | Posted | Number | percentage of participants | Patients were followed until outcome or up to 2 years post-implant, whichever came first |
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| 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. | 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. | Posted | Median | Full Range | units on a scale | Baseline (1 month), 6 months |
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| 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 | 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. | Posted | Median | Full Range | units on a scale | Baseline (1 month), 6 months |
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| 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. | 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. | Posted | Median | Full Range | units on a scale | Baseline (1 month), 6 months |
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| 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. | 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. | Posted | Median | Full Range | units on a scale | Baseline (1 month), 6 months |
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| 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. | 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. | Posted | Median | Full Range | units on a scale | Baseline (1 month), 6 months |
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| 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. | 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. | Posted | Median | Full Range | units on a scale | Baseline (1 month), 6 months |
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| 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. | 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. | Posted | Median | Full Range | Units measured in seconds | Baseline (1 month), 6 months |
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| 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. | 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. | Posted | Median | Full Range | Units measured in seconds | Baseline (1 month), 6 months |
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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
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HeartMate II | Implantation of HeartMate II LVAS | 129 | 133 | 86 | 133 | ||
| EG001 | HeartMate XVE | Implantation of HeartMate XVE LVAS | 58 | 59 | 42 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding (All serious events) | Blood and lymphatic system disorders | Systematic Assessment | events that cause death, reoperations, permanent injury or necessitate transfusion of >2 units of PRBC within 24 hours |
| |
| Bleeding requiring surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment | neurological deficit lasting more than 24 hours or lasting 24 hours or less with a brain imaging study showing new infarction |
| |
| Other neurological | Nervous system disorders | Systematic Assessment | any new, temporary or permanent, focal or global neurological deficit including TIA, metabolic encephalopathy, seizure, etc |
| |
| Local Infection | Infections and infestations | Systematic Assessment | Localized non-device related infections |
| |
| Drive Line Infection | Infections and infestations | Systematic Assessment | infection of the drive line |
| |
| Pocket Infection | Infections and infestations | Systematic Assessment | Infection of the pump pocket |
| |
| Pump Housing | Infections and infestations | Systematic Assessment | Infection of the pump housing |
| |
| Sepsis | Infections and infestations | Systematic Assessment | a systemic response to a serious infection, usually manifested by fever, tachycardia, tachypnea, leukocytosis and vasodilatation requiring use of IV antimicrobial therapy |
| |
| Right Heart Failure (Inotropes) | Cardiac disorders | Systematic Assessment | Need for inotropic support for > 14 days after implant |
| |
| Right Heart Failure (RVAD) | Cardiac disorders | Systematic Assessment | the need for RVAD |
| |
| Peripheral Thromboembolism | Vascular disorders | Systematic Assessment | 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 |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 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 |
| |
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment | any arrhythmia that requires intervention |
| |
| Renal Failure | Renal and urinary disorders | Systematic Assessment | require renal replacement therapy (CVVHD or dialysis) that was not required prior to implant |
| |
| Hepatic Dysfunction | Hepatobiliary disorders | Systematic Assessment | 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) |
| |
| Device Thrombosis | Blood and lymphatic system disorders | Systematic Assessment | 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 |
| |
| Hemolysis | Blood and lymphatic system disorders | Systematic Assessment | two consecutive PHgb values above 40 mg/dl and a LDH value above 1,000mg/dl during the same time |
| |
| Psychological | Psychiatric disorders | Systematic Assessment | disturbance in thinking, emotion or behavior that causes substantial impairment in functioning or marked subjective distress requiring intervention |
| |
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Confirmed Malfunctions | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Local Infection | Infections and infestations | Systematic Assessment |
| ||
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Psychological | Psychiatric disorders | Systematic Assessment |
| ||
| Confirmed Malfunctions | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Poornima Sood, MD, MBA, Sr. Director, Clinical Affairs | Thoratec Corporation | 781 852 8334 | psood@thoratec.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006353 | Heart-Assist Devices |
| ID | Term |
|---|---|
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
| D006354 | Heart, Artificial |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
Not provided
Not provided
| Male |
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| Hispanic |
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| Black or African American |
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| White |
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| Other, unknown |
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| Non-Inferiority or Equivalence (legacy) |
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. |
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