Clinical trial NCT02836652: Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Official title: Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: HeartMate II (HMII)
Left Ventricular Assist Device (LVAD)
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant
timeFrame: 6 months post initial implantation
measure: Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant
timeFrame: 6 months post initial implantation
Secondary outcomes:
Other outcomes:
measure: Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant
timeFrame: 12 months post-implant
measure: Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices
timeFrame: 12 months post-implant
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital at Birmingham (UAB)
state: Alabama
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Richland
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec (Hôpital Laval)
Study officials:
affiliation: Abbott
name: Daniel Crandall
role: STUDY_DIRECTOR
References: