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This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
This is a post-market clinical study of HM II patient management practices to be conducted in the United States.
Subjects will be randomized in a 1:1 fashion to the following research drug groups:
The study will investigate if subjects in the Treatment Arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant |
|
| Control Arm | Active Comparator | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartMate II (HMII) | Device | Left Ventricular Assist Device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant | Composite incidence of non-surgical bleeding at 6 months post initial implantation, including but not limited to gastrointestinal, genitourinary, epistaxis, subdural hematoma, and primary hemorrhagic stroke (not due to ischemic conversion, or due to the treatment of a hemolysis/suspected thrombosis event). | 6 months post initial implantation |
| Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant | Composite incidence of pump thrombosis and thromboembolic stroke at 6 months post initial implantation, including ischemic stroke, or hemorrhagic stroke due to an ischemic conversion/treatment of hemolysis/pump thrombosis event. | 6 months post initial implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant | Rates of bleeding, gastrointestinal (GI) bleeding, suspected and confirmed pump thrombosis, stroke, hemolysis, anticoagulation, survival. | 12 months post-implant |
| Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Crandall | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Hospital at Birmingham (UAB) | Birmingham | Alabama | 35249 | United States | ||
| Ronald Reagan UCLA Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant HeartMate II (HMII): Left Ventricular Assist Device Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care) |
| FG001 | Aspirin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2020 |
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| Warfarin |
| Drug |
(INR Target 2.0-2.5, median 2.25, per standard of patient care) |
|
|
| acetylsalicylic acid (ASA) therapy | Drug | (81mg/day) |
|
|
The PREVENT recommended practices have three objectives: maximizing flow through the pump, reducing the risk of cannula malposition, and ensuring adequate anticoagulation while on left ventricular device support, with the overall goal of reducing pump thrombosis events. These implant techniques are similar to those in the HeartMate II instructions for use, but with modifications derived from clinical experience. |
| 12 months post-implant |
| Los Angeles |
| California |
| 90095 |
| United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| University of California at San Francisco | San Francisco | California | 94131 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Shands at the University of Florida | Gainesville | Florida | 32610 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46240 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| New York Presbyterian Hospital/Columbia University | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11790 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Providence St. Vincent | Portland | Oregon | 97225 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Seton Medical Center | Austin | Texas | 78705 | United States |
| Baylor University Hospital | Dallas | Texas | 75246 | United States |
| Memorial Hermann | Houston | Texas | 77030 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Institut de Cardiologie de Montreal (Montreal Heart Inst.) | Montreal | Quebec | H1T 1C8 | Canada |
| Institut de Cardiologie de Quebec (Hôpital Laval) | Québec | Quebec | G1V 4G5 | Canada |
Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant HeartMate II (HMII): Left Ventricular Assist Device Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care) acetylsalicylic acid (ASA) therapy: (81mg/day) |
| As-treated Population | Cohort of subjects on treatment medication. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
As-treated population: patients that consented to participate in the study and were able to start the research drug within 15 days of HM II implant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant HeartMate II (HMII): Left Ventricular Assist Device Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care) |
| BG001 | Aspirin | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant HeartMate II (HMII): Left Ventricular Assist Device Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care) acetylsalicylic acid (ASA) therapy: (81mg/day) |
| 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 (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Ischemic Heart Failure | Count of Participants | Participants |
| ||||||||||||||||
| History of Atrial Fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| History of Stroke | Count of Participants | Participants |
| ||||||||||||||||
| History of Bleed | Count of Participants | Participants |
| ||||||||||||||||
| History of Gastrointestinal Bleed | Count of Participants | Participants |
| ||||||||||||||||
| History of Myocardial Infarction | Count of Participants | Participants |
| ||||||||||||||||
| History of Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| History of Aortic Stenosis | Count of Participants | Participants |
| ||||||||||||||||
| History of Carotid Artery Disease | Count of Participants | Participants |
| ||||||||||||||||
| Left Ventricular Ejection Fraction (%) - mean ± standard deviation (SD) | Mean | Standard Deviation | % |
| |||||||||||||||
| Right Atrial Pressure (mm-Hg) - mean ± SD | Mean | Standard Deviation | mm-Hg |
| |||||||||||||||
| Mean Arterial Pressure (mm-Hg) - mean ± SD | Mean | Standard Deviation | mm-Hg |
| |||||||||||||||
| Estimated Glomerular Filtration Rate | Mean | Standard Deviation | ml/min/1.73 m^2 |
| |||||||||||||||
| Destination Therapy | Destination therapy is when the device is implanted with the intent of having the device provide long-term or permanent support for the heart as opposed to being a bridge to heart transplant. The left ventricular assist device (LVAD) team makes this determination prior to the LVAD implant based on the patient's cardiac function and other comorbidities, which will also determine their eligibility for receiving a heart transplant. | Count of Participants | Participants |
| |||||||||||||||
| Inter-agency Registry for Mechanically Assisted Circulatory Support (INTERMACS) <= 3 | INTERMACS profiles are commonly used to identify the severity of heart failure. Simplified definitions of profiles 1-3 are listed below.
| Count of Participants | Participants |
| |||||||||||||||
| Cardiac Re-synchronization Therapy with Defibrillator | Count of Participants | 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 | Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant | Composite incidence of non-surgical bleeding at 6 months post initial implantation, including but not limited to gastrointestinal, genitourinary, epistaxis, subdural hematoma, and primary hemorrhagic stroke (not due to ischemic conversion, or due to the treatment of a hemolysis/suspected thrombosis event). | As-treated population | Posted | Count of Participants | Participants | 6 months post initial implantation |
|
|
| |||||||||||||||||||||||||||||
| Primary | Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant | Composite incidence of pump thrombosis and thromboembolic stroke at 6 months post initial implantation, including ischemic stroke, or hemorrhagic stroke due to an ischemic conversion/treatment of hemolysis/pump thrombosis event. | As-treated population | Posted | Count of Participants | Participants | 6 months post initial implantation |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant | Rates of bleeding, gastrointestinal (GI) bleeding, suspected and confirmed pump thrombosis, stroke, hemolysis, anticoagulation, survival. | Posted | Number | percentage of subjects | 12 months post-implant |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices | The PREVENT recommended practices have three objectives: maximizing flow through the pump, reducing the risk of cannula malposition, and ensuring adequate anticoagulation while on left ventricular device support, with the overall goal of reducing pump thrombosis events. These implant techniques are similar to those in the HeartMate II instructions for use, but with modifications derived from clinical experience. | As-treated population | Posted | Number | percentage of subjects | 12 months post-implant |
|
At the end of study follow-up: 12-months HM II implant.
Adverse events and deaths occurring in the "as-treated population" are reported here. This includes patients that consented to participate in the study and were able to start the research drug within 15 days of HM II implant.
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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 | Placebo | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant HeartMate II (HMII): Left Ventricular Assist Device Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care) | 3 | 31 | 21 | 31 | 0 | 31 |
| EG001 | Aspirin | Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant HeartMate II (HMII): Left Ventricular Assist Device Warfarin: (INR Target 2.0-2.5, median 2.25, per standard of patient care) acetylsalicylic acid (ASA) therapy: (81mg/day) | 3 | 34 | 26 | 34 | 0 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Bleeding | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Suspected Pump Thrombosis | Product Issues | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Poornima Sood | Abbott | 7818528334 | poornima.sood@abbott.com |
| Aug 31, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D001241 | Aspirin |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Units | Counts |
|---|
| Participants |
|
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