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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 a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying.
The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.
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. Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Device | Implantation of ventricular assist device to provide hemodynamic support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status). | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Reliability (Malfunctions/Failures) | Confirmed malfunctions/Serious Adverse Events | continuous |
| Kansas City Cardiomyopathy Questionaire (KCCQ) | KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). 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 six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life. |
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Inclusion Criteria:
The following are general criteria; more specific conditions are included in the study protocol:
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 |
|---|---|---|---|
| 17761592 | Result | Miller LW, Pagani FD, Russell SD, John R, Boyle AJ, Aaronson KD, Conte JV, Naka Y, Mancini D, Delgado RM, MacGillivray TE, Farrar DJ, Frazier OH; HeartMate II Clinical Investigators. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. 2007 Aug 30;357(9):885-96. doi: 10.1056/NEJMoa067758. | |
| 24750460 |
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194 patients were followed to at least 1 year after implantation of the device, all 133 of the Pivotal Study Cohort patients and 61 of the US CAP patients, results of which are summarized below and in the final FDA-approved labeling for the HeartMate II LVAS. The remaining 292 patients followed for less than 1 year are not included.
486 patients were recruited at 36 cardiac transplantation hospitals between 8 Mar 2005 and 21 Apr 2008. After enrolling the initial 133 patients prespecified by the study protocol, an additional 353 patients were enrolled under a Continued Access Protocol(CAP) and in a concurrent Canadian study.
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| ID | Title | Description |
|---|---|---|
| FG000 | HeartMate II (HMII) | HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| baseline to 6 months |
| 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, 1 month, 3 months, 6 months |
| 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' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life. | Baseline to 6 months |
| 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 to 6 months |
| Reoperations | Additional surgery after the initial implant operation | continuous |
| Post-transplant Survival | 30 day and 1 year post transplant survival | 30 days, 1 year |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Shands Hospital @ University of Florida | Gainesville | Florida | 32610 | United States |
| Methodist Hospital | Indianapolis | Indiana | 46206 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | 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 |
| Barnes-Jewish Hospital/Washington University | St Louis | Missouri | 63110 | 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 |
| 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 | 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 |
| 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. |
| 19933938 | Derived | Russell SD, Rogers JG, Milano CA, Dyke DB, Pagani FD, Aranda JM, Klodell CT Jr, Boyle AJ, John R, Chen L, Massey HT, Farrar DJ, Conte JV; HeartMate II Clinical Investigators. Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device. Circulation. 2009 Dec 8;120(23):2352-7. doi: 10.1161/CIRCULATIONAHA.108.814863. Epub 2009 Nov 23. |
| 19608028 | Derived | Pagani FD, Miller LW, Russell SD, Aaronson KD, John R, Boyle AJ, Conte JV, Bogaev RC, MacGillivray TE, Naka Y, Mancini D, Massey HT, Chen L, Klodell CT, Aranda JM, Moazami N, Ewald GA, Farrar DJ, Frazier OH; HeartMate II Investigators. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009 Jul 21;54(4):312-21. doi: 10.1016/j.jacc.2009.03.055. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HM II | HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol) |
| 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 |
| ||||||||||||||||||
| Body Surface Area | Body Surface Area (BSA) calculated from patients height and weight | Mean | Standard Deviation | sq. meter |
| ||||||||||||||||
| Cardiac Index | Mean | Standard Deviation | L/min/m^2 |
| |||||||||||||||||
| PCWP | Pulmonary capillary wedge pressure | Mean | Standard Deviation | mmHg |
|
| 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 | Survival | Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status). | The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT). | Posted | Number | participants | 180 days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Reliability (Malfunctions/Failures) | Confirmed malfunctions/Serious Adverse Events | Posted | Number | Number of Serious Events | continuous |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Kansas City Cardiomyopathy Questionaire (KCCQ) | KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). 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 six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life. | Patients alive and capable of performing the test at 6 months | Posted | Mean | Standard Error | Units on a KCCQ Score scale | baseline to 6 months |
|
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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 | All patients who survived to interval are included. | Posted | Mean | Full Range | units on NYHA scale | baseline, 1 month, 3 months, 6 months |
|
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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' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life. | Patients alive and capable of performing the test at 6 months | Posted | Mean | Standard Error | units on a MLWHF Score scale | Baseline to 6 months |
|
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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. | Mean change from baseline in 6MWT distance at Month 1, 3, and 6. Only patients alive, capable and willing to perform test are included. | Posted | Mean | Standard Error | meters | baseline to 6 months |
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| Secondary | Reoperations | Additional surgery after the initial implant operation | The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT). | Posted | Number | Number of Events | continuous |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Post-transplant Survival | 30 day and 1 year post transplant survival | Patients (n=112) who recieved a cardiac transplant were followed at 30 day and 1 year post-transplant to determine if the device influenced post-transplant survival. | Posted | Number | percentage of participants | 30 days, 1 year |
|
|
From time of device implant to time of cardiac transplantation, permanent device removal, or death.
Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HMII | HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP). | 194 | 194 | 36 | 194 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | General disorders | Protocol and CEC | Systematic Assessment |
| |
| Bleeding requiring surgery | Blood and lymphatic system disorders | Protocol and CEC | Systematic Assessment |
| |
| Stroke | Nervous system disorders | Protocol and CEC | Systematic Assessment |
| |
| Driveline infection | Infections and infestations | Protocol and CEC | Systematic Assessment |
| |
| Pocket infection | Infections and infestations | Protocol and CEC | Systematic Assessment |
| |
| Sepsis | Infections and infestations | Protocol and CEC | Systematic Assessment |
| |
| Right heart failure | Cardiac disorders | Protocol and CEC | Systematic Assessment |
| |
| Device thrombosis | Blood and lymphatic system disorders | Protocol and CEC | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | Protocol and CEC | Systematic Assessment |
| |
| Other neurological | Nervous system disorders | Protocol and CEC | Systematic Assessment | Includes transient ischemic attachs (TIA) and non-stroke neurological events. |
|
| Local infection | Infections and infestations | Protocol and CEC | Systematic Assessment |
| |
| Peripheral Thromboembolism | Blood and lymphatic system disorders | Protocol and CEC | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Protocol and CEC | Systematic Assessment |
| |
| Cardiac arrhythmias | Cardiac disorders | Protocol and CEC | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | Protocol and CEC | Systematic Assessment |
| |
| Hepatic dysfunction | Hepatobiliary disorders | Protocol and CEC | Systematic Assessment |
| |
| Psychological | Psychiatric disorders | Protocol and CEC | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | Protocol and CEC | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | General disorders | Protocol and CEC | Systematic Assessment | Non-serious bleeding events |
|
| Localized Infection | General disorders | Protocol and CEC | Systematic Assessment | Non-serious localized infection |
|
| Driveline Infection | General disorders | Protocol and CEC | Systematic Assessment | Non-serious driveline infection |
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| Cardiac Arrhythmias | General disorders | Protocol and CEC | Systematic Assessment | Non-serious cardiac arrhythmias |
|
| Psychological | General disorders | Protocol and CEC | Systematic Assessment | Non-serious psychological |
|
| Device Malfunctions | General disorders | Protocol and CEC | Systematic Assessment | Non-serious device malfunctions |
|
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| 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 |
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| 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 |
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| Title | Measurements |
|---|---|
|
| Alive on device at 180 days, not Status 1A or 1B |
|
| Received other ventricular assist device |
|
| Expired prior to 180 days while on VAD support |
|
| Categories |
|---|
| Pump |
| |||||
| Inflow Cannula |
| |||||
| Outflow Cannula |
| |||||
| System Controller |
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| System Monitor |
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| Display Module |
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| Power Base Unit |
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| Power Base Unit Cable |
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| Batteries |
| |||||
| Battery Clips |
| |||||
| Shower Kit |
| |||||
| Surgical Accessories |
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|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Survival at 30 days (%) |
| |||||
| Survival at 1 year (%) |
|