Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy (PREVENT II)
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ClinicalTrials.gov Identifier: NCT02836652 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Results First Posted : October 29, 2020
Last Update Posted : October 29, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Device: HeartMate II (HMII) Drug: Warfarin Drug: acetylsalicylic acid (ASA) therapy | Phase 4 |
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.
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 |

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 |
- 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).
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Poornima Sood, M.D. | Abbott Medical Devices |
Documents provided by Abbott Medical Devices:
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 |
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 |
HeartMate II (HMII) Left Ventricular Assist Device (LVAD) |
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 |