The ARIES HeartMate 3 Pump IDE Study

Heart Failure Clinical Trial

Official title:

Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069156
• Other study ID #: ABT-CIP-10305
• Status: Completed
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: August 10, 2023

Study information

• Verified date: December 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.

2. Subject will receive the HeartMate 3 as their first durable VAD.

3. Subject must provide written informed consent prior to any clinical investigation related procedure.

4. In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.

Exclusion Criteria:

1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).

2. Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).

3. Patients who are nil per os (NPO) post-implant through day 7.

4. Subjects with a known allergy to acetylsalicylic acid (aspirin).

5. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.

6. 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• LVAD Implant
Subjects will undergo Heartmate 3 LVAD implant prior to randomization

Drug:
• Aspirin 100mg
Subjects will be randomized to either Placebo or Aspirin post implant.
• Placebo oral tablet
Subjects will be randomized to either Placebo or Aspirin post implant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czechia,  France,  Italy,  Kazakhstan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Hemocompatibility Score (HCS)	This study will also assess changes in the hemocompatibility score as a result of removal of antiplatelet therapy from the antithrombotic regimen	Up to 3 years post implant
Other	Rate of Rehospitalization	This study will also assess changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen	Up to 3 years post implant
Other	Economic Cost Implications	This study will also assess changes in the cost implications as a result of removal of antiplatelet therapy from the antithrombotic regimen	Up to 3 years post implant
Primary	Non-Inferiority Primary Endpoint	The primary endpoint for this study will be met if the placebo arm is non-inferior to the aspirin arm in the composite of survival free of any non-surgical (any event occuring > 14 days post implant) major hemocompatibility related adverse event (Stroke, pump thrombosis, bleeding [intracranial bleeds that do not meet stroke definition], arterial peripheral thromboembolism), at 1-year post implant	1 year post implant
Secondary	Rate of Non-surgical Major Hemorrhagic Events	The non-surgical major hemorrhagic events will be compared between the two arms of the study.	Up to 3 years post implant
Secondary	Rate of Non-surgical Major Thrombotic Events	The non-surgical major thrombotic events will be compared between the two arms of the study.	Up to 3 years post implant
Secondary	Rate of Survival	Survival will be compared between the two arms of the study.	Up to 3 years post implant
Secondary	Rate of Stroke Rates	Stroke rates will be compared between the two arms of the study.	Up to 3 years post implant
Secondary	Rate of Pump Thrombosis Rates	Pump thrombosis rates will be compared between the two arms of the study.	Up to 3 years post implant
Secondary	Rate of Bleeding Rates	Bleeding rates will be compared between the two arms of the study.	Up to 3 years post implant