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

NCT02836652 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-06-27

Study results available
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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.

Conditions

Interventions

DEVICE

HeartMate II (HMII)

Left Ventricular Assist Device

DRUG

Warfarin

(INR Target 2.0-2.5, median 2.25, per standard of patient care)

DRUG

acetylsalicylic acid (ASA) therapy

(81mg/day)

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Daniel Crandall · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-02-21
Completion
2019-07-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02836652 on ClinicalTrials.gov