Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836652
Recruitment Status : Completed
First Posted : July 19, 2016
Results First Posted : October 29, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: HeartMate II (HMII) Drug: Warfarin Drug: acetylsalicylic acid (ASA) therapy Phase 4

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment Arm
Warfarin (INR Target 2.0-2.5, median 2.25, per standard of patient care) + placebo (1 pill/day) post HeartMate II implant
 Device: HeartMate II (HMII)
Left Ventricular Assist Device

Drug: Warfarin
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
Other Name: Coumadin
Active Comparator: Control Arm
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
 Device: HeartMate II (HMII)
Left Ventricular Assist Device

Drug: Warfarin
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
Other Name: Coumadin

Drug: acetylsalicylic acid (ASA) therapy
(81mg/day)
Other Name: Aspirin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant [ Time Frame: 6 months post initial implantation ]
    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).

  2. Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant [ Time Frame: 6 months post initial implantation ]
    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.


Other Outcome Measures:
  1. Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant [ Time Frame: 12 months post-implant ]
    Rates of bleeding, gastrointestinal (GI) bleeding, suspected and confirmed pump thrombosis, stroke, hemolysis, anticoagulation, survival.

  2. Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices [ Time Frame: 12 months post-implant ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836652


Locations
Show Show 35 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Poornima Sood, M.D. Abbott Medical Devices
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol and Statistical Analysis Plan  [PDF] July 16, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02836652    
Other Study ID Numbers: SJM-CIP-10134
First Posted: July 19, 2016    Key Record Dates
Results First Posted: October 29, 2020
Last Update Posted: October 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Keywords provided by Abbott Medical Devices:
HeartMate II (HMII)
Left Ventricular Assist Device (LVAD)
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants