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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
Scientific title
Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
Secondary ID [1] 0 0
ABT-CIP-10305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Non-Inferiority Primary Endpoint
Timepoint [1] 0 0
1 year post implant
Secondary outcome [1] 0 0
Rate of Non-surgical Major Hemorrhagic Events
Timepoint [1] 0 0
Up to 3 years post implant
Secondary outcome [2] 0 0
Rate of Non-surgical Major Thrombotic Events
Timepoint [2] 0 0
Up to 3 years post implant
Secondary outcome [3] 0 0
Rate of Survival
Timepoint [3] 0 0
Up to 3 years post implant
Secondary outcome [4] 0 0
Rate of Stroke Rates
Timepoint [4] 0 0
Up to 3 years post implant
Secondary outcome [5] 0 0
Rate of Pump Thrombosis Rates
Timepoint [5] 0 0
Up to 3 years post implant
Secondary outcome [6] 0 0
Rate of Bleeding Rates
Timepoint [6] 0 0
Up to 3 years post implant

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/08/2023
Sample size
Target
Accrual to date
Final
628
Recruitment in Australia
Recruitment state(s)
NewVIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Austria
State/province [23] 0 0
Vienna
Country [24] 0 0
Canada
State/province [24] 0 0
Edmonton
Country [25] 0 0
Czechia
State/province [25] 0 0
Central Bohemia
Country [26] 0 0
France
State/province [26] 0 0
Pessac
Country [27] 0 0
France
State/province [27] 0 0
Toulouse
Country [28] 0 0
Italy
State/province [28] 0 0
Milan
Country [29] 0 0
Kazakhstan
State/province [29] 0 0
Astana
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To be determined


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