NCT02836652

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-02-21
• Completion: 2019-07-18
• First posted: 2016-07-19
• Last updated: 2022-06-27
• Results posted: 2020-10-29

Locations

35 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study
• FDA-regulated device study