A Phase 4 interventional study of HeartMate II (HMII) and Warfarin in Heart Failure, sponsored by Abbott Medical Devices. Completed at 35 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by Abbott Medical Devices · Phase 4, Interventional, and Treatment
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.
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:
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.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 72 is close to the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
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) · Drug: Warfarin
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) · Drug: Warfarin · Drug: acetylsalicylic acid (ASA) therapy
Left Ventricular Assist Device
(INR Target 2.0-2.5, median 2.25, per standard of patient care)
Also known as: Coumadin
(81mg/day)
Also known as: Aspirin
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).
Time frame: 6 months post initial implantation
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.
Time frame: 6 months post initial implantation
Descriptive Endpoint: Percent of Patients With Adverse Events at 1-year Post HeartMate II Implant
Rates of bleeding, gastrointestinal (GI) bleeding, suspected and confirmed pump thrombosis, stroke, hemolysis, anticoagulation, survival.
Time frame: 12 months post-implant
Adherence to Prevention of HeartMate II Pump Thrombosis Through Clinical Management (PREVENT) Study Recommended Practices
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
| Milestone | Placebo | Aspirin |
|---|---|---|
| Started | 35 | 37 |
| As-treated population | 31 | 34 |
| Completed | 17 | 18 |
| Not completed | 18 | 19 |
| Withdrew: Death | 3 | 3 |
| Withdrew: Transplant/explant | 3 | 4 |
| Withdrew: Withdrawn | 9 | 9 |
| Withdrew: Not on treatment regimen post-op day 15 | 3 | 3 |
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).
| Participants | Placebo | Aspirin |
|---|---|---|
| Safety Endpoint: % of Patients With Non-surgical Bleeding at 6 Months Post HeartMate II Implant | 12 | 15 |
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.
| Participants | Placebo | Aspirin |
|---|---|---|
| Efficacy Endpoint: % of Patients With Thromboembolic Events at 6 Months Post HeartMate II Implant | 4 | 3 |
Rates of bleeding, gastrointestinal (GI) bleeding, suspected and confirmed pump thrombosis, stroke, hemolysis, anticoagulation, survival.
| percentage of subjects | Placebo | Aspirin |
|---|---|---|
| Major Bleeding | 38.7 | 64.7 |
| GI Bleeding | 25.8 | 29.4 |
| Ischemic Stroke | 12.9 | 14.7 |
| Hemorrhagic Stroke | 6.5 | 5.9 |
| Transient Ischemic Attack | 9.7 | 0 |
| Hemolysis | 22.6 | 17.6 |
| Suspected Pump Thrombosis | 9.7 | 8.8 |
| Confirmed Pump Thrombosis | 6.5 | 5.9 |
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.
| percentage of subjects | Placebo | Aspirin |
|---|---|---|
| Was the pump pocket adequately sized? | 100 | 100 |
| Was the pump pocket inferiorly deep and lateral? | 100 | 100 |
| Was the pump positioned below the diaphragm? | 100 | 100 |
| Was the pump anchored? | 76.7 | 85.3 |
| Was inflow cannula parallel to septum and oriented | 100 | 100 |
| Location of core: True Apex | 46.7 | 52.9 |
| Does the outflow graft avoid the right ventricle? | 93.3 | 100 |
| Was Heparin Bridging started? | 76.7 | 85.3 |
| Was Warfarin initiated within 48 hours post HMII i | 66.7 | 50.0 |
| Was a goal INR of 2.0 - 2.5 achieved in post-op da | 50.0 | 26.5 |
| Was the treatment drug therapy initiated within 5 | 76.7 | 73.5 |
| Pump speed <9000 leaving OR? | 45.2 | 41.2 |
| Pump speed < 9000 at 30 days? | 14.3 | 9.4 |
Collected over At the end of study follow-up: 12-months HM II implant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 3/31 (9.7%) | 21/31 (67.7%) | 0/31 (0%) |
| Aspirin | 3/34 (8.8%) | 26/34 (76.5%) | 0/34 (0%) |
| Event | Placebo | Aspirin |
|---|---|---|
| Major BleedingVascular disorders | 12/31 | 22/34 |
| HemolysisBlood and lymphatic system disorders | 7/31 | 6/34 |
| StrokeNervous system disorders | 6/31 | 7/34 |
| Suspected Pump ThrombosisProduct Issues | 3/31 | 3/34 |
As-treated population: patients that consented to participate in the study and were able to start the research drug within 15 days of HM II implant.
| Age, Continuous(years) | Placebo | Aspirin | Total |
|---|---|---|---|
| Mean | 68.2 ± 5.9 | 65.6 ± 6.5 | 66.8 ± 6.3 |
| Sex: Female, Male(Participants) | Placebo | Aspirin | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 25 | 31 | 56 |
| Race (NIH/OMB)(Participants) | Placebo | Aspirin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 5 | 9 | 14 |
| White | 23 | 24 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Placebo | Aspirin | Total |
|---|---|---|---|
| United States | 35 | 37 | 72 |
| Ischemic Heart Failure(Participants) | Placebo | Aspirin | Total |
|---|---|---|---|
| Count of participants | 15 | 24 | 39 |
| History of Atrial Fibrillation(Participants) | Placebo | Aspirin | Total |
|---|---|---|---|
| Count of participants | 13 | 14 | 27 |
| History of Stroke(Participants) | Placebo | Aspirin | Total |
|---|---|---|---|
| Count of participants | 6 | 2 | 8 |
| History of Bleed(Participants) | Placebo | Aspirin | Total |
|---|---|---|---|
| Count of participants | 1 | 5 | 6 |
12 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Abbott Medical Devices