The ARIES HeartMate 3 Pump IDE Study

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    628
  • sponsor
    Abbott Medical Devices
Updated on 13 February 2021
aspirin
heart failure

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

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.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment Placebo Oral Tablet, Aspirin 100mg, LVAD Implant
Clinical Study IdentifierNCT04069156
SponsorAbbott Medical Devices
Last Modified on13 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Heart disease or Cardiac Disease or Congestive Heart Failure or Heart failure?
Do you have any of these conditions: Cardiac Disease or Heart failure or cardiac failure or Heart disease or congestive heart disease or Congestive Heart Failure?
Do you have any of these conditions: Cardiac Disease or congestive heart disease or Heart failure or Heart disease or Congestive Heart Failure or cardiac failure?
Do you have any of these conditions: cardiac failure or Congestive Heart Failure or Heart disease or congestive heart disease or Heart failure or Cardiac Disease?
Do you have any of these conditions: Heart disease or cardiac failure or Heart failure or Congestive Heart Failure or Cardiac Disease or congestive heart disease?
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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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