Prevent II

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

Prevent II [NCT02836652]

Description:  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.

Device: HeartMate II (HMII)

Drug: Warfarin

Drug: acetylsalicylic acid (ASA) therapy

Primary Investigator: Egnaczyk

Drug/Device Information
Device: HeartMate II (HMII)
Drug: acetylsalicylic acid (ASA) therapy
Drug: Warfarin
Objectives: reduce the incidence of non-surgical bleeding in HeartMate II (HM II) patients without increasing the risk of thromboembolic (TE) events
This is a post-market clinical study of HM II patient management practices to be conducted in the United States
Randomized 1:1 to either the treatment arm - Warfarin (INR target: 2.0-2.5) + Placebo versus the control arm - Warfarin (INR target: 2.0-2.5) + ASA Therapy (81mg/day)
St. Jude Medical, Inc.