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.
Brief Title
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure
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
* 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
Inclusion 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).
* 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).
Gender
All
Gender Based
false
Keywords
HeartMate II (HMII)
Left Ventricular Assist Device (LVAD)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
50 Years
NCT Id
NCT02836652
Org Class
Industry
Org Full Name
Abbott Medical Devices
Org Study Id
SJM-CIP-10134
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Primary Outcomes
Outcome 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).
Outcome Measure
Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant
Outcome Time Frame
6 months post initial implantation
Outcome 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.
Outcome Measure
Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant
Outcome Time Frame
6 months post initial implantation
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
Omar Saeed
Investigator Email
osaeed@montefiore.org
Investigator Phone
Categories Mesh Debug
Heart/Cardiovascular --- HEART FAILURE
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
HEART FAILURE
HEART DISEASES
CARDIOVASCULAR DISEASES
WARFARIN
ASPIRIN
THERAPEUTICS
4-HYDROXYCOUMARINS
COUMARINS
BENZOPYRANS
PYRANS
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
SALICYLATES
HYDROXYBENZOATES
PHENOLS
BENZENE DERIVATIVES
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
ORGANIC CHEMICALS