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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
HeartMate II (HMII)
Warfarin
acetylsalicylic acid (ASA) therapy
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring HeartMate II (HMII), Left Ventricular Assist Device (LVAD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Hospital at Birmingham (UAB)
  • Ronald Reagan UCLA Medical Center
  • Sharp Memorial Hospital
  • University of California at San Francisco
  • Washington Hospital Center
  • Shands at the University of Florida
  • Florida Hospital
  • Piedmont Hospital
  • St. Vincent Hospital
  • Kansas University Medical Center
  • Ochsner Medical Center
  • Tufts Medical Center
  • Henry Ford Hospital
  • University of Minnesota Medical Center Fairview
  • Mayo Clinic
  • Montefiore Medical Center
  • New York Presbyterian Hospital/Columbia University
  • University of Rochester Medical Center
  • Stony Brook University Medical Center
  • Westchester Medical Center
  • University of North Carolina at Chapel Hill
  • Christ Hospital
  • Ohio State University
  • Integris Baptist Medical Center
  • Providence St. Vincent
  • Thomas Jefferson University Hospital
  • Temple University Hospital
  • Palmetto Health Richland
  • Baptist Memorial Hospital
  • Seton Medical Center
  • Baylor University Hospital
  • Memorial Hermann
  • St. Luke's Medical Center
  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Institut de Cardiologie de Quebec (Hôpital Laval)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2016
Last Updated
June 23, 2022
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02836652
Brief Title
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Acronym
PREVENT II
Official Title
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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: Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
HeartMate II (HMII), Left Ventricular Assist Device (LVAD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
HeartMate II (HMII)
Intervention Description
Left Ventricular Assist Device
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid (ASA) therapy
Other Intervention Name(s)
Aspirin
Intervention Description
(81mg/day)
Primary Outcome Measure Information:
Title
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant
Description
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).
Time Frame
6 months post initial implantation
Title
Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant
Description
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.
Time Frame
6 months post initial implantation
Other Pre-specified Outcome Measures:
Title
Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant
Description
Rates of bleeding, gastrointestinal (GI) bleeding, suspected and confirmed pump thrombosis, stroke, hemolysis, anticoagulation, survival.
Time Frame
12 months post-implant
Title
Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices
Description
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.
Time Frame
12 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Crandall
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Hospital at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94131
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Shands at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Presbyterian Hospital/Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Providence St. Vincent
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Palmetto Health Richland
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Seton Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut de Cardiologie de Quebec (Hôpital Laval)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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