The ARIES HeartMate 3 Pump IDE Study

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Device: LVAD Implant
Drug: Aspirin 100mg
Drug: Placebo oral tablet

Registration Number: NCT04069156

Lead Sponsor: Abbott Medical Devices

Brief 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

Detailed Description: This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 628

Inclusion Criteria

Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
Subject will receive the HeartMate 3 as their first durable VAD.
Subject must provide written informed consent prior to any clinical investigation related procedure.
In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.

Exclusion Criteria

Post-implant additional temporary or permanent mechanical circulatory support (MCS).
Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
Patients who are nil per os (NPO) post-implant through day 7.
Subjects with a known allergy to acetylsalicylic acid (aspirin).
Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	LVAD Implant	LVAD Patients on the placebo arm will be given placebo medication
Active Arm	Aspirin 100mg	LVAD Patients on the active arm will be given 100mg Aspirin
Placebo Arm	Placebo oral tablet	LVAD Patients on the placebo arm will be given placebo medication
Active Arm	LVAD Implant	LVAD Patients on the active arm will be given 100mg Aspirin

Primary Outcome Measures

Name	Time	Method
Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events	12 Months	The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.

Secondary Outcome Measures

Name	Time	Method
Rates of Non-surgical Major Hemorrhagic Events	Through Study Completion with a Median Follow up of 14 Months	The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure.
Rates of Bleeding Events	Through Study Completion with a Median Follow up of 14 Months	The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support).
Rates of Non-surgical Major Thrombotic Events	Through Study Completion with a Median Follow up of 14 Months	The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure
Rates of Stroke	Through Study Completion with a Median Follow up of 14 Months	The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support).
Survival Rates	24 Months	The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant.
Risk of Non-Surgical Bleeding Events	24 Months	Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test.

Trial Locations

Locations (51): Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
National Research Center for Cardiac Surgery
🇰🇿
Astana, Kazakhstan
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Miami Transplant Institute - Jackson Memorial
🇺🇸
Miami, Florida, United States
St. Vincent Hospital
🇺🇸
Indianapolis, Indiana, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
Minneapolis Heart Institute
🇺🇸
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
🇺🇸
Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
California Pacific Medical Center - Van Ness Campus
🇺🇸
San Francisco, California, United States
Integris Baptist Medical Center
🇺🇸
Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute
🇺🇸
Portland, Oregon, United States
University of Utah Hospital
🇺🇸
Salt Lake City, Utah, United States
Queen Elizabeth Hospital
🇬🇧
Birmingham, United Kingdom
University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
Baptist Health Medical Center
🇺🇸
Little Rock, Arkansas, United States
University of California, San Diego
🇺🇸
La Jolla, California, United States
Stanford University Medical Center
🇺🇸
Palo Alto, California, United States
AdventHealth Orlando
🇺🇸
Orlando, Florida, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Ochsner Medical Center
🇺🇸
New Orleans, Louisiana, United States
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
New York-Presbyterian/Columbia University Medical Center
🇺🇸
New York, New York, United States
Montefiore Medical Center - Moses Division
🇺🇸
New York, New York, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States
University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Allegheny General Hospital - ASRI
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Baylor University Hospital
🇺🇸
Dallas, Texas, United States
Memorial Hermann Hospital
🇺🇸
Houston, Texas, United States
Aurora Medical Group
🇺🇸
Milwaukee, Wisconsin, United States
St. Vincent's Hospital, Sydney
🇦🇺
Darlinghurst, New, Australia
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
AKH - Wien
🇦🇹
Vienna, Austria
IKEM Prague
🇨🇿
Prague, Central Bohemia, Czechia
University of Alberta Hospital
🇨🇦
Edmonton, Canada
Hopital Haut Leveque
🇫🇷
Pessac, France
CHU Rangueil Toulouse
🇫🇷
Toulouse, France
Ospedale San Raffaele
🇮🇹
Milan, Italy