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The ARIES HeartMate 3 Pump IDE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069156
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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

Condition or disease Intervention/treatment Phase
Heart Failure Device: LVAD Implant Drug: Aspirin 100mg Drug: Placebo oral tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, randomized 1:1, active arm versus placebo arm
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigator, site, patient, CEC, and core lab are blinded.
Primary Purpose: Supportive Care
Official Title: Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Aspirin

Arm Intervention/treatment
Placebo Comparator: Placebo Arm
LVAD Patients on the placebo arm will be given placebo medication
Device: LVAD Implant
Subjects will undergo Heartmate 3 LVAD implant prior to randomization

Drug: Placebo oral tablet
Subjects will be randomized to either Placebo or Aspirin post implant

Active Comparator: Active Arm
LVAD Patients on the active arm will be given 100mg Aspirin
Device: LVAD Implant
Subjects will undergo Heartmate 3 LVAD implant prior to randomization

Drug: Aspirin 100mg
Subjects will be randomized to either Placebo or Aspirin post implant.




Primary Outcome Measures :
  1. Non-inferority Primary Endpoint [ Time Frame: 1 year post implant ]
    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


Secondary Outcome Measures :
  1. Non-Surgical Bleeding Secondary Endpoint [ Time Frame: Up to 3 years post implant ]
    The non-surgical bleeding rate per patient year will be compared between treatment groups in the Primary Endpoint Population using Poisson regression.

  2. Antiplatelet Therapy Removal Safety Endpoint [ Time Frame: Up to 3 years post implant ]
    To assess the safety of removal of antiplatelet therapy from the antithrombotic regimen between the two arms of the study using all patient follow up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069156


Contacts
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Contact: Nina Sinanovic 4084257259 nina.sinanovic@abbott.com
Contact: Daniel Crandall, PhD 7815528016 daniel.crandall5@abbott.com

Locations
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United States, Arkansas
Baptist Health Medical Center Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Jay Bhama, MD    601-202-1500    jkbhama@me.com   
Contact: John Ransom, MD    (501) 202-1500    johnransom1@aol.com   
Principal Investigator: Jay Bhama, MD         
Principal Investigator: John Ransom, MD         
Sub-Investigator: Patrick Campbell         
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Robert Adamson, MD    858-939-7471    rmadamsonmd@hotmail.com   
Contact: Chris Kohlmyer    (858) 244-6886    ckohlmyer@sdcardiac.com   
Principal Investigator: Robert Adamson, MD         
Sub-Investigator: Brian Jaski, MD         
California Pacific Medical Center - Van Ness Campus Recruiting
San Francisco, California, United States, 94109
Contact: Brett Sheridan, MD    415-600-5780    sheridbc@PAMF.org   
Contact: Milena Ferreira    (415) 600-5707    ferreiml@sutterhealth.org   
Principal Investigator: Brett Sheridan, MD         
Sub-Investigator: Michael Pham, MD         
Sub-Investigator: Jared Herr, MD         
Sub-Investigator: Yu Xie, MD         
Sub-Investigator: Ranjan Ray, MD         
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Jennifer Cowger, MD    313-850-3015    jcowger1@hfhs.org   
Contact: Kelsey Neaton    (313) 829-3570    Kneaton1@hfhs.org   
Principal Investigator: Jennifer Cowger, MD         
United States, New York
New York-Presbyterian/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Nir Uriel, MD    212-342-1327    nu2126@cumc.columbia.edu   
Contact: Dawn Scotto    (212) 305-1368    des2164@cumc.columbia.edu   
Principal Investigator: Nir Uriel, MD         
Sub-Investigator: Gabriel Sayer, MD         
Sub-Investigator: Yoshifumi Naka, MD         
Sub-Investigator: Koji Takeda, MD         
Sub-Investigator: Paolo Colombo, MD         
Sub-Investigator: Veli Topkara, MD         
Sub-Investigator: Melana Yuzefpolskaya, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Poornima Sood, MD, MBA Clinical Program Director
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04069156    
Other Study ID Numbers: ABT-CIP-10305
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Abbott Medical Devices:
heart failure
ventricular assist device
LVAD
aspirin
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics