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

NCT ID: NCT02836652

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-07-18

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

HeartMate II (HMII)

Intervention Type: DEVICE

Left Ventricular Assist Device

Warfarin

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

HeartMate II (HMII)

Intervention Type: DEVICE

Left Ventricular Assist Device

Warfarin

Intervention Type: DRUG

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

acetylsalicylic acid (ASA) therapy

Intervention Type: DRUG

(81mg/day)

Interventions

HeartMate II (HMII)

Left Ventricular Assist Device

Intervention Type: DEVICE

Warfarin

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

Intervention Type: DRUG

acetylsalicylic acid (ASA) therapy

(81mg/day)

Intervention Type: DRUG

Other Intervention Names

Coumadin; Aspirin

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Crandall

Role: STUDY_DIRECTOR

Abbott

Locations

University of Alabama Hospital at Birmingham (UAB)

Birmingham, Alabama, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Sharp Memorial Hospital

San Diego, California, United States

University of California at San Francisco

San Francisco, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Shands at the University of Florida

Gainesville, Florida, United States

Florida Hospital

Orlando, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

New York Presbyterian Hospital/Columbia University

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Westchester Medical Center

Valhalla, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Christ Hospital

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Providence St. Vincent

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Palmetto Health Richland

Columbia, South Carolina, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Seton Medical Center

Austin, Texas, United States

Baylor University Hospital

Dallas, Texas, United States

Memorial Hermann

Houston, Texas, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10134

Identifier Type: -

Identifier Source: org_study_id