Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | LVAD Patients on the placebo arm will be given placebo medication |
|
| Active Arm | Active Comparator | LVAD Patients on the active arm will be given 100mg Aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVAD Implant | Device | Subjects will undergo Heartmate 3 LVAD implant prior to randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Non-surgical Major Hemorrhagic Events | The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure. | Through Study Completion with a Median Follow up of 14 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Rehospitalization | This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen. | Through Study Completion with a Median Follow up of 14 Months |
| Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health Medical Center | Little Rock | Arkansas | 72205 | United States | ||
| University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37950897 | Background | Mehra MR, Netuka I, Uriel N, Katz JN, Pagani FD, Jorde UP, Gustafsson F, Connors JM, Ivak P, Cowger J, Ransom J, Bansal A, Takeda K, Agarwal R, Byku M, Givertz MM, Bitar A, Hall S, Zimpfer D, Vega JD, Kanwar MK, Saeed O, Goldstein DJ, Cogswell R, Sheikh FH, Danter M, Pya Y, Phancao A, Henderson J, Crandall DL, Sundareswaran K, Soltesz E, Estep JD; ARIES-HM3 Investigators. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2171-2181. doi: 10.1001/jama.2023.23204. | |
| 39774588 |
Not provided
Not provided
To be determined
Not provided
Not provided
Not provided
Not provided
The intent to treat (ITT) population consisted of all subjects randomized including follow up beyond transition to open label (n=314 in each arm).
The study enrolled and randomized 628 subjects at 51 sites. Enrollment took place between July 2020 and September 2022, with the last subject follow up concluding in August 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Arm | Patients randomized to the placebo arm were given placebo medication. |
| FG001 | Aspirin Arm | Patients randomized to the aspirin arm were given aspirin medication (100mg/day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Modified Intent-to-Treat (mITT) |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2020 | Aug 8, 2024 |
Not provided
Not provided
Double-blinded, randomized 1:1, active arm versus placebo arm
Not provided
Not provided
Investigator, site, patient, CEC, and core lab are blinded.
| Aspirin 100mg | Drug | Subjects will be randomized to either Placebo or Aspirin post implant. |
|
| Placebo oral tablet | Drug | Subjects will be randomized to either Placebo or Aspirin post implant |
|
| Rates of Bleeding Events | The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support). | Through Study Completion with a Median Follow up of 14 Months |
| Rates of Non-surgical Major Thrombotic Events | The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure | Through Study Completion with a Median Follow up of 14 Months |
| Rates of Stroke | The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support). | Through Study Completion with a Median Follow up of 14 Months |
| Survival Rates | The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant. | 24 Months |
| Risk of Non-Surgical Bleeding Events | Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test. | 24 Months |
Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included. |
| 12 Months |
| Economic Cost Implications - Average Cost Per Bleeding Event | These values were derived by dividing the total estimated cost for bleeding events by the number of events to determine the average cost per bleeding event. Consequently, a measure of dispersion is not available for these outcomes. | 12 Months |
| Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant | These values were derived by dividing the total estimated cost for bleeding events by the number of patients to obtain the average cost per study patient. Consequently, a measure of dispersion is not available for these outcomes. | 12 Months |
| Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant | Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included. | 12 Months |
| La Jolla |
| California |
| 92037 |
| United States |
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| California Pacific Medical Center - Van Ness Campus | San Francisco | California | 94109 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Miami Transplant Institute - Jackson Memorial | Miami | Florida | 33136 | United States |
| AdventHealth Orlando | Orlando | Florida | 32804 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | 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 |
| 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 Hospital | Detroit | Michigan | 48202 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | 10032 | United States |
| Montefiore Medical Center - Moses Division | New York | New York | 10467 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Providence Heart & Vascular Institute | Portland | Oregon | 97225 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor University Hospital | Dallas | Texas | 75246 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | United States |
| St. Vincent's Hospital, Sydney | Darlinghurst | New | 2010 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| AKH - Wien | Vienna | 1090 | Austria |
| University of Alberta Hospital | Edmonton | T6G 2B7 | Canada |
| IKEM Prague | Prague | Central Bohemia | 140 24 | Czechia |
| Hopital Haut Leveque | Pessac | 33600 | France |
| CHU Rangueil Toulouse | Toulouse | 31000 | France |
| Ospedale San Raffaele | Milan | Italy |
| National Research Center for Cardiac Surgery | Astana | 10000 | Kazakhstan |
| Queen Elizabeth Hospital | Birmingham | B15 2GW | United Kingdom |
| Background |
| Gustafsson F, Uriel N, Netuka I, Katz JN, Pagani FD, Connors JM, Jorde UP, Zimpfer D, Pya Y, Conway J, Anyanwu A, Scandroglio AM, Sulemanjee N, Atluri P, Keebler M, Selzman CH, Alexis JD, Hayward C, Henderson J, Dirckx N, Gazzola C, Mehra MR; ARIES Investigators. Aspirin and Hemocompatibility After LVAD Implantation in Patients With Atherosclerotic Vascular Disease: A Secondary Analysis From the ARIES-HM3 Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):235-242. doi: 10.1001/jamacardio.2024.4849. |
| 34142415 | Background | Mehra MR, Crandall DL, Gustafsson F, Jorde UP, Katz JN, Netuka I, Uriel N, Connors JM, Sood P, Heatley G, Pagani FD. Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial. Eur J Heart Fail. 2021 Jul;23(7):1226-1237. doi: 10.1002/ejhf.2275. Epub 2021 Jul 1. |
| 41258850 | Derived | Katz JN, Connors JM, Pagani FD, Jorde UP, Gustafsson F, Uriel N, Netuka I, Byku M, Anyanwu A, Keebler M, Nathan S, Selzman CH, Alexis JD, Sulemanjee N, Atluri P, D'Allesandro D, Porter S, Lee FS, Mehra MR; ARIES Investigators. Hemocompatibility Outcomes With Pharmacological Therapy Following LVAD Implantation: Insights From the ARIES-HM3 Trial. JACC Heart Fail. 2026 Mar;14(3):102769. doi: 10.1016/j.jchf.2025.102769. Epub 2025 Nov 19. |
| 40208135 | Derived | Pagani FD, Netuka I, Jorde UP, Katz JN, Gustafsson F, Connors JM, Uriel N, Soltesz EG, Ivak P, Bansal A, Bitar A, Vega JD, Goldstein D, Danter M, Pya Y, Ravichandran A, Conway J, Adler ED, Chung ES, Grinstein J, Dirckx N, Iravani B, Mehra MR. Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy. JACC Heart Fail. 2025 Jul;13(7):102411. doi: 10.1016/j.jchf.2025.01.017. Epub 2025 Apr 9. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Principal Analysis |
|
|
The Modified Intention to Treat Population (mITT) included all randomized subjects with the following exception:
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Arm | Patients randomized to the placebo arm were given placebo medication. |
| BG001 | Aspirin Arm | Patients randomized to the aspirin arm were given aspirin medication (100mg/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 |
| ||||||||||||||||
| Heart Failure Etiology | Count of Participants | Participants |
| ||||||||||||||||
| Intended Use | Count of Participants | Participants |
| ||||||||||||||||
| INTERMACS Profile | INTERMACS profiles describe the clinical profile of advanced heart failure patients who may be candidates for mechanical circulatory support. There are 7 profiles ranging from Profile 1 (most sick) to Profile 7 (least sick). Profile 1 indicates critical cardiogenic shock. Profile 2 indicates progressive decline. Profile 3 indicates stable but inotrope dependent. Profile 4 indicates resting symptoms. Profile 5 indicates exertion intolerant. Profile 6 indicates exertion limited. Profile 7 indicates advanced NYHA Class 3 (clinically stable with a reasonable level of comfortable activity). | Count of Participants | Participants |
| |||||||||||||||
| New York Heart Association (NYHA) Class | The NYHA functional classification consists of four categories, with Class IV being the worse class.
| Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | 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 | Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant. | The primary end point was analyzed in the principal analysis population, which excluded patients with events occurring within 14 days after LVAD implantation to avoid counting surgical complications not attributed to the treatment. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rates of Non-surgical Major Hemorrhagic Events | The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure. | Modified Intention to Treat Population (mITT) | Posted | Number | Event Per 100 Patient-Year | Through Study Completion with a Median Follow up of 14 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rates of Bleeding Events | The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support). | Modified Intention to Treat Population (mITT) | Posted | Number | Event Per 100 Patient-Year | Through Study Completion with a Median Follow up of 14 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rates of Non-surgical Major Thrombotic Events | The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure | Modified Intention to Treat Population (mITT) | Posted | Number | Event Per 100 Patient-Year | Through Study Completion with a Median Follow up of 14 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rates of Stroke | The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support). | Modified Intention to Treat Population (mITT) | Posted | Number | Event Per 100 Patient-Year | Through Study Completion with a Median Follow up of 14 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Survival Rates | The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant. | Modified Intention to Treat Population (mITT) | Posted | Number | Percentage of Participants | 24 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Risk of Non-Surgical Bleeding Events | Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test. | Modified Intention to Treat Population | Posted | Number | Percentage of Participants | 24 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Rehospitalization | This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen. | Modified Intention to Treat Population | Posted | Number | Event Per 100 Patient-Year | Through Study Completion with a Median Follow up of 14 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis) | Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included. | Only US subjects were included in this analysis | Posted | Number | USD | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Economic Cost Implications - Average Cost Per Bleeding Event | These values were derived by dividing the total estimated cost for bleeding events by the number of events to determine the average cost per bleeding event. Consequently, a measure of dispersion is not available for these outcomes. | Only US subjects were included in this analysis | Posted | Number | USD | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant | These values were derived by dividing the total estimated cost for bleeding events by the number of patients to obtain the average cost per study patient. Consequently, a measure of dispersion is not available for these outcomes. | Only US subjects were included in this analysis | Posted | Number | USD | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant | Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included. | Only US subjects were included in this analysis | Posted | Number | USD/1000 implants/1 year | 12 Months |
|
|
All adverse events occurring through study completion (median follow up of 14 months) were collected.
An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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 | Placebo Arm (Modified Intent-to-treat Population) | Patients randomized to the placebo arm were given placebo medication. | 21 | 296 | 208 | 296 | 200 | 296 |
| EG001 | Aspirin Arm (Modified Intent-to-treat Population) | Patients randomized to the aspirin arm were given aspirin medication (100mg/day). | 22 | 293 | 223 | 293 | 181 | 293 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Hemolysis | Blood and lymphatic system disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Cardiac Arrhythmia | Cardiac disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Right Heart Failure | Cardiac disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Hepatic Dysfunction | Hepatobiliary disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Major Infection | Infections and infestations | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Neurologic Dysfunction | Nervous system disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Renal Dysfunction | Renal and urinary disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Venous Thromboembolism | Vascular disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Hypertension | Vascular disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Blood And Lymphatic System Disorders | Blood and lymphatic system disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Cardiac Disorders | Cardiac disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Ear And Labyrinth Disorders | Ear and labyrinth disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Endocrine Disorders | Endocrine disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Eye Disorders | Eye disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| General Disorders And Administration Site Conditions | Gastrointestinal disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Immune System Disorders | Immune system disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Infections And Infestations | Infections and infestations | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Investigations | Investigations | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Metabolism And Nutrition Disorders | Metabolism and nutrition disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Nervous System Disorders | Nervous system disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Pregnancy, Puerperium And Perinatal Conditions | Pregnancy, puerperium and perinatal conditions | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Renal And Urinary Disorders | Renal and urinary disorders | Study Protocol | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Social Circumstances | Social circumstances | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Surgical And Medical Procedures | Surgical and medical procedures | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Vascular Disorders | Vascular disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Infection | Infections and infestations | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Cardiac Arrhythmia | Cardiac disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Hepatic Dysfunction | Hepatobiliary disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Venous Thromboembolism | Vascular disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Bleeding | Blood and lymphatic system disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Renal Dysfunction | Renal and urinary disorders | Study Protocol | Systematic Assessment | Site reported event terms were used for protocol defined adverse events. |
|
| Blood And Lymphatic System Disorders | Blood and lymphatic system disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Cardiac Disorders | Cardiac disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Eye Disorders | Eye disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Study Protocol | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| General Disorders And Administration Site Conditions | General disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Infections And Infestations | Infections and infestations | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Investigations | Investigations | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Metabolism And Nutrition Disorders | Metabolism and nutrition disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Nervous System Disorders | Nervous system disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Renal And Urinary Disorders | Renal and urinary disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Reproductive System And Breast Disorders | Reproductive system and breast disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
| Vascular Disorders | Vascular disorders | MedDRA system | Systematic Assessment | Other events reported by MedDRA system organ classification. |
|
We excluded patients with early surgical complications or those that required mechanical support devices in addition to the implanted LVAD, or when investigators deemed aspirin therapy necessary.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nourdine Chakouri, PhD | Abbott | (925) 989-5982 | nourdine.chakouri@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2023 | Aug 8, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Idiopathic Cardiomyopathy |
|
| Dilated Cardiomyopathy |
|
| Other |
|
| Bridge to Candidacy for Transplantation |
|
| Destination Therapy |
|
| Bridge to Recovery |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Class IIIA |
|
| Class IIIB |
|
| Class IV |
|
| Other |
|
|
|
|
|
|
|
|
|
|
|
|