MedTrace Logo

The ARIES HeartMate 3 Pump IDE Study

NCT04069156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2025-03-27

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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.

DRUG

Placebo oral tablet

Subjects will be randomized to either Placebo or Aspirin post implant

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2023-08-10
Completion
2023-08-10
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Italy
  • Kazakhstan
  • United Kingdom

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 NCT04069156 on ClinicalTrials.gov