Trial · NCT04069156
The ARIES HeartMate 3 Pump IDE Study
NCT04069156, Not applicable, Completed, Abbott Medical Devices; results first posted 2025-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The ARIES HeartMate 3 Pump IDE Study. Trials, record NCT04069156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04069156
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The ARIES HeartMate 3 Pump IDE Study
- NCT number
- NCT04069156
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 628 participants, actual
- Lead sponsor
- Abbott Medical Devices
- Conditions
- Heart Failure
- Interventions
- LVAD Implant, Aspirin 100mg, Placebo oral tablet
- First posted
- 2019-08-28
- Last updated
- 2025-03-27
- Results first posted
- 2025-03-27
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | 12 Months | 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. |
| Secondary | Rates of Non-surgical Major Hemorrhagic Events | Through Study Completion with a Median Follow up of 14 Months | 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. |
| Secondary | Rates of Bleeding Events | Through Study Completion with a Median Follow up of 14 Months | The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support). |
| Secondary | Rates of Non-surgical Major Thrombotic Events | Through Study Completion with a Median Follow up of 14 Months | 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 |
| Secondary | Rates of Stroke | Through Study Completion with a Median Follow up of 14 Months | 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). |
| Secondary | Survival Rates | 24 Months | 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. |
| Secondary | Risk of Non-Surgical Bleeding Events | 24 Months | Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test. |
| Other | Rate of Rehospitalization | Through Study Completion with a Median Follow up of 14 Months | This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen. |
| Other | Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis) | 12 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. |
| Other | Economic Cost Implications - Average Cost Per Bleeding Event | 12 Months | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | 12 Months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rates of Non-surgical Major Hemorrhagic Events | Through Study Completion with a Median Follow up of 14 Months | Modified Intention to Treat Population (mITT) | Event Per 100 Patient-Year | NUMBER |
| SECONDARY | Rates of Bleeding Events | Through Study Completion with a Median Follow up of 14 Months | Modified Intention to Treat Population (mITT) | Event Per 100 Patient-Year | NUMBER |
| SECONDARY | Rates of Non-surgical Major Thrombotic Events | Through Study Completion with a Median Follow up of 14 Months | Modified Intention to Treat Population (mITT) | Event Per 100 Patient-Year | NUMBER |
| SECONDARY | Rates of Stroke | Through Study Completion with a Median Follow up of 14 Months | Modified Intention to Treat Population (mITT) | Event Per 100 Patient-Year | NUMBER |
| SECONDARY | Survival Rates | 24 Months | Modified Intention to Treat Population (mITT) | Percentage of Participants | NUMBER |
| SECONDARY | Risk of Non-Surgical Bleeding Events | 24 Months | Modified Intention to Treat Population | Percentage of Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Rate of Rehospitalization | Through Study Completion with a Median Follow up of 14 Months | Modified Intention to Treat Population | Event Per 100 Patient-Year | NUMBER |
| OTHER_PRE_SPECIFIED | Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis) | 12 Months | Only US subjects were included in this analysis | USD | NUMBER |
| OTHER_PRE_SPECIFIED | Economic Cost Implications - Average Cost Per Bleeding Event | 12 Months | Only US subjects were included in this analysis | USD | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | Placebo Arm (Principal Analysis Population) | 201 | Participants | ||
| Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | Aspirin Arm (Principal Analysis Population) | 186 | Participants | ||
| Rates of Non-surgical Major Hemorrhagic Events | Placebo Arm (Modified Intent-to-treat Population) | All Non-surgical Major Hemorrhagic events | 26.2 | Event Per 100 Patient-Year | |
| Rates of Non-surgical Major Hemorrhagic Events | Aspirin Arm (Modified Intent-to-treat Population) | All Non-surgical Major Hemorrhagic events | 40.7 | Event Per 100 Patient-Year | |
| Rates of Non-surgical Major Hemorrhagic Events | Placebo Arm (Modified Intent-to-treat Population) | Bleeding | 25.93 | Event Per 100 Patient-Year | |
| Rates of Non-surgical Major Hemorrhagic Events | Aspirin Arm (Modified Intent-to-treat Population) | Bleeding | 39.53 | Event Per 100 Patient-Year | |
| Rates of Non-surgical Major Hemorrhagic Events | Placebo Arm (Modified Intent-to-treat Population) | Hemorrhagic Stroke | 0.27 | Event Per 100 Patient-Year | |
| Rates of Non-surgical Major Hemorrhagic Events | Aspirin Arm (Modified Intent-to-treat Population) | Hemorrhagic Stroke | 0.85 | Event Per 100 Patient-Year | |
| Rates of Non-surgical Major Hemorrhagic Events | Placebo Arm (Modified Intent-to-treat Population) | Ischemic Stroke with Hemorrhagic Conversion | 0.00 | Event Per 100 Patient-Year | |
| Rates of Non-surgical Major Hemorrhagic Events | Aspirin Arm (Modified Intent-to-treat Population) | Ischemic Stroke with Hemorrhagic Conversion | 0.28 | Event Per 100 Patient-Year |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Modified Intent-to-Treat (mITT) | STARTED | Placebo Arm | 314 | |
| Modified Intent-to-Treat (mITT) | STARTED | Aspirin Arm | 314 | |
| Modified Intent-to-Treat (mITT) | COMPLETED | Placebo Arm | 296 | |
| Modified Intent-to-Treat (mITT) | COMPLETED | Aspirin Arm | 293 | |
| Modified Intent-to-Treat (mITT) | NOT COMPLETED | Placebo Arm | 18 | |
| Modified Intent-to-Treat (mITT) | NOT COMPLETED | Aspirin Arm | 21 | |
| Principal Analysis | STARTED | Placebo Arm | 296 | |
| Principal Analysis | STARTED | Aspirin Arm | 293 | |
| Principal Analysis | COMPLETED | Placebo Arm | 271 | |
| Principal Analysis | COMPLETED | Aspirin Arm | 273 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events118
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Major Infection | Infections and infestations | Placebo Arm (Modified Intent-to-treat Population) | 94 | 296 | 129 |
| other | Major Infection | Infections and infestations | Aspirin Arm (Modified Intent-to-treat Population) | 92 | 293 | 118 |
| other | Cardiac Arrhythmia | Cardiac disorders | Placebo Arm (Modified Intent-to-treat Population) | 8 | 296 | 9 |
| other | Cardiac Arrhythmia | Cardiac disorders | Aspirin Arm (Modified Intent-to-treat Population) | 11 | 293 | 12 |
| other | Hepatic Dysfunction | Hepatobiliary disorders | Placebo Arm (Modified Intent-to-treat Population) | 5 | 296 | 5 |
| other | Hepatic Dysfunction | Hepatobiliary disorders | Aspirin Arm (Modified Intent-to-treat Population) | 6 | 293 | 6 |
| other | Venous Thromboembolism | Vascular disorders | Placebo Arm (Modified Intent-to-treat Population) | 4 | 296 | 4 |
| other | Venous Thromboembolism | Vascular disorders | Aspirin Arm (Modified Intent-to-treat Population) | 4 | 293 | 4 |
| other | Bleeding | Blood and lymphatic system disorders | Placebo Arm (Modified Intent-to-treat Population) | 3 | 296 | 4 |
| other | Bleeding | Blood and lymphatic system disorders | Aspirin Arm (Modified Intent-to-treat Population) | 1 | 293 | 1 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Arm (Modified Intent-to-treat Population) | 21 | 296 |
| Total, all-cause mortality | Aspirin Arm (Modified Intent-to-treat Population) | 22 | 293 |
| Total, other adverse events | Placebo Arm (Modified Intent-to-treat Population) | 200 | 296 |
| Total, other adverse events | Aspirin Arm (Modified Intent-to-treat Population) | 181 | 293 |
| Total, serious adverse events | Placebo Arm (Modified Intent-to-treat Population) | 208 | 296 |
| Total, serious adverse events | Aspirin Arm (Modified Intent-to-treat Population) | 223 | 293 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aspirin Arm (Principal Analysis Population) vs Placebo Arm (Principal Analysis Population): Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | Trial comparisons |
| Aspirin Arm (Modified Intent-to-treat Population) vs Placebo Arm (Modified Intent-to-treat Population): deaths from any cause | Trial comparisons |
| Aspirin Arm (Modified Intent-to-treat Population) vs Placebo Arm (Modified Intent-to-treat Population): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04069156
GET https://conductscience.org/api/trials/v1/NCT04069156/results?page=2