Heart FailureNCT04069156
The ARIES HeartMate 3 Pump IDE Study
A study testing LVAD Implant and Aspirin 100mg in people with Heart Failure, run by Abbott Medical Devices at 51 sites in 9 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- LVAD Implant and Aspirin 100mg
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 628 participants
- Where
- 51 sitesin 9 countries
- Study dates
- 14 Jul 2020to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
- Subject will receive the HeartMate 3 as their first durable VAD.
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.
Who cannot join
- Post-implant additional temporary or permanent mechanical circulatory support (MCS).
- Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
- Patients who are nil per os (NPO) post-implant through day 7.
- Subjects with a known allergy to acetylsalicylic acid (aspirin).
- Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Trial locations and contacts
51 sites in 9 countries.
51 sites in 9 countries
United States41 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado Hospital
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Chicago
Chicago, Illinois, 60637
The Christ Hospital
Cincinnati, Ohio, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Hospital
Dallas, Texas, 75246
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Memorial Hermann Hospital
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46240
Kansas University Medical Center
Kansas City, Kansas, 66160
University of California, San Diego
La Jolla, California, 92037
Baptist Health Medical Center
Little Rock, Arkansas, 72205
Miami Transplant Institute - Jackson Memorial
Miami, Florida, 33136
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Ochsner Medical Center
New Orleans, Louisiana, 70121
Mount Sinai Hospital
New York, New York, 10029
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
Montefiore Medical Center - Moses Division
New York, New York, 10467
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
AdventHealth Orlando
Orlando, Florida, 32804
Stanford University Medical Center
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Providence Heart & Vascular Institute
Portland, Oregon, 97225
University of Rochester Medical Center
Rochester, New York, 14642
University of Utah Hospital
Salt Lake City, Utah, 84132
Sharp Memorial Hospital
San Diego, California, 92123
California Pacific Medical Center - Van Ness Campus
San Francisco, California, 94109
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Australia2 sites
St. Vincent's Hospital, Sydney
Darlinghurst, New, 2010
The Alfred Hospital
Melbourne, Victoria, 3004
France2 sites
Hopital Haut Leveque
Pessac, 33600
CHU Rangueil Toulouse
Toulouse, 31000
Kazakhstan1 site
National Research Center for Cardiac Surgery
Astana, 10000
About this study
Official title: Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
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
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- LVAD Implant, Aspirin 100mg, Placebo oral tablet
- Keywords
- heart failure, ventricular assist device, LVAD, aspirin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVAD ImplantDevice
Subjects will undergo Heartmate 3 LVAD implant prior to randomization
Aspirin 100mgDrug
Subjects will be randomized to either Placebo or Aspirin post implant.
Placebo oral tabletDrug
Subjects will be randomized to either Placebo or Aspirin post implant
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | LVAD Patients on the placebo arm will be given placebo medication Receives: Device: LVAD Implant; Drug: Placebo oral tablet |
| Active Arm | Active comparator | LVAD Patients on the active arm will be given 100mg Aspirin Receives: Device: LVAD Implant; Drug: Aspirin 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (6)
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.
Measured: Through Study Completion with a Median Follow up of 14 Months
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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start14 Jul 2020
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized 1:1, active arm versus placebo arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069156
- Sponsor's protocol ID
- ABT-CIP-10305
- Status last verified
- Jan 2025
- First submitted
- 21 Aug 2019
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To be determined
Publications
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.
PubMed 37950897Gustafsson 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.
PubMed 39774588Mehra 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.
PubMed 34142415Katz 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.
PubMed 41258850Pagani 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.
PubMed 40208135
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
- ClinicalTrials.gov ID
- NCT04069156
- Acronym / sponsor ID
- ABT-CIP-10305
- Conditions
- Heart Failure
- Keywords
- heart failure, ventricular assist device, LVAD, aspirin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, randomized 1:1, active arm versus placebo arm
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Device: LVAD Implant, Drug: Placebo oral tabletLVAD Patients on the placebo arm will be given placebo medication |
| Active Arm | Active comparator | Device: LVAD Implant, Drug: Aspirin 100mgLVAD Patients on the active arm will be given 100mg Aspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
- Subject will receive the HeartMate 3 as their first durable VAD.
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.
Key exclusion criteria (6 listed)
- Post-implant additional temporary or permanent mechanical circulatory support (MCS).
- Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
- Patients who are nil per os (NPO) post-implant through day 7.
- Subjects with a known allergy to acetylsalicylic acid (aspirin).
- Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVAD ImplantSubjects will undergo Heartmate 3 LVAD implant prior to randomization | Device | Active Arm, Placebo Arm |
| Aspirin 100mgSubjects will be randomized to either Placebo or Aspirin post implant. | Drug | Active Arm |
| Placebo oral tabletSubjects will be randomized to either Placebo or Aspirin post implant | Drug | Placebo Arm |
Primary outcome
Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events
Time frame: 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.
6 secondary outcomes
Rates of Non-surgical Major Hemorrhagic Events
Time frame: Through Study Completion with a Median Follow up of 14 Months
Rates of Bleeding Events
Time frame: Through Study Completion with a Median Follow up of 14 Months
Rates of Non-surgical Major Thrombotic Events
Time frame: Through Study Completion with a Median Follow up of 14 Months
Rates of Stroke
Time frame: Through Study Completion with a Median Follow up of 14 Months
Survival Rates
Time frame: 24 Months
Risk of Non-Surgical Bleeding Events
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37950897Mehra 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.
- Background: PubMed 39774588Gustafsson 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.
- Background: PubMed 34142415Mehra 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.
- Derived from this study: PubMed 41258850Katz 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.
- Derived from this study: PubMed 40208135Pagani 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.
- Individual participant dataSharing planned: No. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVAD Implant and Aspirin 100mg in people with Heart Failure, run by Abbott Medical Devices at 51 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Australia, France, Austria, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069156, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.