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Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

NCT02836652•Abbott Medical Devices

View on ClinicalTrials.gov

Summary

This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.

Detailed Description

This is a post-market clinical study of HM II patient management practices to be conducted in the United States. Subjects will be randomized in a 1:1 fashion to the following research drug groups: 1. Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day) 2. Control Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + ASA Therapy (81mg/day) The study will investigate if subjects in the Treatment Arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use
•Subject is ≥ 50 years of age
•Subject is receiving the HM II as their first LVAD
•Subject or legally authorized representative (LAR) has signed an informed consent form (ICF).

Exclusion Criteria

•Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Impella® devices
•Participation in any other clinical investigation(s) involving an MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
•Antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-ASA or starting ASA post LVAD implantation. In situations where the investigator is uncertain, the Steering Committee can provide recommendation to the investigator as needed.
•Subjects in whom heart transplantation is expected in ≤ 6 months
•Subjects with a known ASA allergy

Locations (35)

University of Alabama Hospital at Birmingham (UAB)

Birmingham, Alabama, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Sharp Memorial Hospital

San Diego, California, United States

University of California at San Francisco

San Francisco, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Shands at the University of Florida

Gainesville, Florida, United States

Florida Hospital

Orlando, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Key Dates

Start Date

November 1, 2016

Primary Completion Date

February 21, 2019

Completion Date

July 18, 2019

Last Updated

June 27, 2022

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

HeartMate II (HMII)

DEVICE

Warfarin

DRUG

acetylsalicylic acid (ASA) therapy

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

Inclusion Criteria

Exclusion Criteria

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