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

Heart Failure Clinical Trial

— PREVENT II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836652
• Other study ID #: SJM-CIP-10134
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: July 18, 2019

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 18, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• HeartMate II (HMII)
Left Ventricular Assist Device

Drug:
• Warfarin
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
• acetylsalicylic acid (ASA) therapy
(81mg/day)

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec
Canada	Institut de Cardiologie de Quebec (Hôpital Laval)	Quebec
United States	Piedmont Hospital	Atlanta	Georgia
United States	Seton Medical Center	Austin	Texas
United States	University of Alabama Hospital at Birmingham (UAB)	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Christ Hospital	Cincinnati	Ohio
United States	Palmetto Health Richland	Columbia	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	Baylor University Hospital	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Shands at the University of Florida	Gainesville	Florida
United States	Memorial Hermann	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	New York Presbyterian Hospital/Columbia University	New York	New York
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Providence St. Vincent	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	Sharp Memorial Hospital	San Diego	California
United States	University of California at San Francisco	San Francisco	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Westchester Medical Center	Valhalla	New York
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,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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