Adults 18 to 100, any sex, with Advanced Refractory Left Ventricular Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Short Term Primary End PointPrimary· The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.
Survival at 6 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Group
Value
95% CI
HeartMate II (Intent-to-Treat)
109
HeartMate 3 (Intent-to-Treat)
131
Long Term Primary End PointPrimary· The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Survival at 2 years free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Group
Value
95% CI
HeartMate II (Intent-to-Treat)
106
HeartMate 3 (Intent-to-Treat)
151
Powered Secondary End Point: Pump Replacement at Two YearsSecondary· As they occur up to 24 months or to Outcome, whichever occurs first
In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.
Group
Value
95% CI
HeartMate II (As-Treated)
57
HeartMate 3 (As-Treated)
12
EuroQoL 5D-5L (EQ-5D-5L) Total ScoreSecondary· Baseline to 24 months
Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Baseline
Group
Value
95% CI
HeartMate II (As-Treated)
11.2
± 4.4
HeartMate 3 (As-Treated)
11.1
± 4.3
6 months
Group
Value
95% CI
HeartMate II (As-Treated)
8.5
± 3.2
HeartMate 3 (As-Treated)
8.5
± 3.3
24 months
Group
Value
95% CI
HeartMate II (As-Treated)
9.2
± 3.8
HeartMate 3 (As-Treated)
8.8
± 3.6
EuroQol-5D-5L Visual Analogue ScaleSecondary· Baseline to 24 months
Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.
Baselline
Group
Value
95% CI
HeartMate II (As-Treated)
48
± 25
HeartMate 3 (As-Treated)
50
± 24
6 months
Group
Value
95% CI
HeartMate II (As-Treated)
74
± 19
HeartMate 3 (As-Treated)
76
± 18
24 months
Group
Value
95% CI
HeartMate II (As-Treated)
75
± 19
HeartMate 3 (As-Treated)
76
± 19
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary ScoreSecondary· Baseline to 24 months
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Baseline
Group
Value
95% CI
HeartMate II (As-Treated)
40
± 23
HeartMate 3 (As-Treated)
39
± 20
6 months
Group
Value
95% CI
HeartMate II (As-Treated)
70
± 21
HeartMate 3 (As-Treated)
70
± 20
24 months
Group
Value
95% CI
HeartMate II (As-Treated)
68
± 23
HeartMate 3 (As-Treated)
69
± 22
Six Minute Walk TestSecondary· Baseline to 24 months
Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.
Baseline
Group
Value
95% CI
HeartMate II (As-Treated)
129
± 156
HeartMate 3 (As-Treated)
136
± 160
6 months
Group
Value
95% CI
HeartMate II (As-Treated)
327
± 136
HeartMate 3 (As-Treated)
310
± 142
24 months
Group
Value
95% CI
HeartMate II (As-Treated)
361
± 337
HeartMate 3 (As-Treated)
323
± 156
New York Heart Association (NYHA) ClassificationSecondary· Baseline to 24 months
Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes f
Class I or II at Baseline
Group
Value
95% CI
HeartMate II (As-Treated)
0
HeartMate 3 (As-Treated)
0
Class I or II at 6 Months
Group
Value
95% CI
HeartMate II (As-Treated)
310
HeartMate 3 (As-Treated)
340
Class I or II at 24 Months
Group
Value
95% CI
HeartMate II (As-Treated)
176
HeartMate 3 (As-Treated)
219
RehospitalizationsSecondary· From initial discharge to two years post-implant
Rate of all cause rehospitalization
Group
Value
95% CI
HeartMate II (As-Treated)
2.47
HeartMate 3 (As-Treated)
2.26
Adverse Event RatesSecondary· Two years post-implant
Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Arterial Non-CNS Thromboembolism
Group
Value
95% CI
HeartMate II (As-Treated)
0.02
HeartMate 3 (As-Treated)
0.01
Bleeding
Group
Value
95% CI
HeartMate II (As-Treated)
0.95
HeartMate 3 (As-Treated)
0.61
Cardiac Arrhythmia
Group
Value
95% CI
HeartMate II (As-Treated)
0.45
HeartMate 3 (As-Treated)
0.37
Hepatic Dysfunction
Group
Value
95% CI
HeartMate II (As-Treated)
0.04
HeartMate 3 (As-Treated)
0.03
Hypertension
Group
Value
95% CI
HeartMate II (As-Treated)
0.08
HeartMate 3 (As-Treated)
0.07
Major Infection
Group
Value
95% CI
HeartMate II (As-Treated)
0.82
HeartMate 3 (As-Treated)
0.82
Myocardial Infarction
Group
Value
95% CI
HeartMate II (As-Treated)
0.01
HeartMate 3 (As-Treated)
0.01
Stroke
Group
Value
95% CI
HeartMate II (As-Treated)
0.18
HeartMate 3 (As-Treated)
0.08
Adverse events — posted to ClinicalTrials.gov
Time frame: Two years post-implant.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 27 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02224755.