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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04069156
Registration number
NCT04069156
Ethics application status
Date submitted
21/08/2019
Date registered
28/08/2019
Titles & IDs
Public title
The ARIES HeartMate 3 Pump IDE Study
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Scientific title
Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
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Secondary ID [1]
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ABT-CIP-10305
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - LVAD Implant
Treatment: Drugs - Aspirin 100mg
Treatment: Drugs - Placebo oral tablet
Placebo comparator: Placebo Arm - LVAD Patients on the placebo arm will be given placebo medication
Active comparator: Active Arm - LVAD Patients on the active arm will be given 100mg Aspirin
Treatment: Devices: LVAD Implant
Subjects will undergo Heartmate 3 LVAD implant prior to randomization
Treatment: Drugs: Aspirin 100mg
Subjects will be randomized to either Placebo or Aspirin post implant.
Treatment: Drugs: Placebo oral tablet
Subjects will be randomized to either Placebo or Aspirin post implant
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Non-Inferiority Primary Endpoint
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Assessment method [1]
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The primary endpoint for this study will be met if the placebo arm is non-inferior to the aspirin arm in the composite of survival free of any non-surgical (any event occuring \> 14 days post implant) major hemocompatibility related adverse event (Stroke, pump thrombosis, bleeding \[intracranial bleeds that do not meet stroke definition\], arterial peripheral thromboembolism), at 1-year post implant
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Timepoint [1]
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1 year post implant
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Secondary outcome [1]
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Rate of Non-surgical Major Hemorrhagic Events
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Assessment method [1]
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The non-surgical major hemorrhagic events will be compared between the two arms of the study.
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Timepoint [1]
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Up to 3 years post implant
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Secondary outcome [2]
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Rate of Non-surgical Major Thrombotic Events
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Assessment method [2]
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The non-surgical major thrombotic events will be compared between the two arms of the study.
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Timepoint [2]
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Up to 3 years post implant
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Secondary outcome [3]
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Rate of Survival
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Assessment method [3]
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Survival will be compared between the two arms of the study.
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Timepoint [3]
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Up to 3 years post implant
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Secondary outcome [4]
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Rate of Stroke Rates
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Assessment method [4]
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Stroke rates will be compared between the two arms of the study.
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Timepoint [4]
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Up to 3 years post implant
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Secondary outcome [5]
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Rate of Pump Thrombosis Rates
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Assessment method [5]
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Pump thrombosis rates will be compared between the two arms of the study.
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Timepoint [5]
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Up to 3 years post implant
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Secondary outcome [6]
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Rate of Bleeding Rates
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Assessment method [6]
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Bleeding rates will be compared between the two arms of the study.
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Timepoint [6]
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Up to 3 years post implant
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Eligibility
Key inclusion criteria
1. Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
2. Subject will receive the HeartMate 3 as their first durable VAD.
3. Subject must provide written informed consent prior to any clinical investigation related procedure.
4. In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).
2. Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
3. Patients who are nil per os (NPO) post-implant through day 7.
4. Subjects with a known allergy to acetylsalicylic acid (aspirin).
5. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
6. 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/08/2023
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Sample size
Target
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Accrual to date
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Final
628
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Recruitment in Australia
Recruitment state(s)
NewVIC
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Recruitment hospital [1]
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St. Vincent's Hospital, Sydney - Darlinghurst
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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Arkansas
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California
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Edmonton
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Pessac
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France
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Toulouse
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Milan
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Kazakhstan
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Astana
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United Kingdom
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Birmingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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
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Trial website
https://clinicaltrials.gov/study/NCT04069156
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
To be determined
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04069156