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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: HeartMate II (HMII); Drug: Warfarin; Drug: acetylsalicylic acid (ASA) therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut de Cardiologie de Quebec (Hôpital Laval)
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama Hospital at Birmingham (UAB)
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Francisco, California, United States, 94131
      • University of California at San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands at the University of Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • St. Vincent Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital/Columbia University
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Stony Brook, New York, United States, 11790
      • Stony Brook University Medical Center
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health Richland
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Seton Medical Center
    • Dallas, Texas, United States, 75246
      • Baylor University Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant	Device: HeartMate II (HMII); Left Ventricular Assist Device; Drug: Warfarin; (INR Target 2.0-2.5, median 2.25, per standard of patient care); Other Names: Coumadin
Active Comparator: Control Arm; Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + acetylsalicylic acid (ASA) therapy (81mg/day) post HeartMate II implant	Device: HeartMate II (HMII); Left Ventricular Assist Device; Drug: Warfarin; (INR Target 2.0-2.5, median 2.25, per standard of patient care); Other Names: Coumadin; Drug: acetylsalicylic acid (ASA) therapy; (81mg/day); Other Names: Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant	Composite incidence of non-surgical bleeding at 6 months post initial implantation, including but not limited to gastrointestinal, genitourinary, epistaxis, subdural hematoma, and primary hemorrhagic stroke (not due to ischemic conversion, or due to the treatment of a hemolysis/suspected thrombosis event).	6 months post initial implantation
Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant	Composite incidence of pump thrombosis and thromboembolic stroke at 6 months post initial implantation, including ischemic stroke, or hemorrhagic stroke due to an ischemic conversion/treatment of hemolysis/pump thrombosis event.	6 months post initial implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant	Rates of bleeding, gastrointestinal (GI) bleeding, suspected and confirmed pump thrombosis, stroke, hemolysis, anticoagulation, survival.	12 months post-implant
Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices	The PREVENT recommended practices have three objectives: maximizing flow through the pump, reducing the risk of cannula malposition, and ensuring adequate anticoagulation while on left ventricular device support, with the overall goal of reducing pump thrombosis events. These implant techniques are similar to those in the HeartMate II instructions for use, but with modifications derived from clinical experience.	12 months post-implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Daniel Crandall, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): February 21, 2019
• Study Completion (Actual): July 18, 2019

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: HeartMate II (HMII); Left Ventricular Assist Device (LVAD)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Anticoagulants; Aspirin; Warfarin
• Other Study ID Numbers: SJM-CIP-10134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes