An observational study in Heart Failure, Cardiovascular Disease and Ventricular Dysfunction, sponsored by Abbott Medical Devices. Completed at 26 sites in 11 countries. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
The purpose of this post-market registry is to collect data and evaluate the real-world experience of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 540 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients that receive the HeartMate 3 LVAS in the post-approval setting
Inclusion:
This registry will include all patients that receive the HM3 LVAS in the post-market setting
Device: HeartMate 3
Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3
Also known as: HM3
Survival
Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
Time frame: Up to 5 Years post-implant
EuroQoL-5D-5L (EQ-5D-5L) VAS
EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).
Time frame: Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS
Six Minute Walk Test (6MWT)
The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
Time frame: At 5 years after implant
New York Heart Association (NYHA) Classification
NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Time frame: At 5 years after implant
Adverse Events
Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)
Time frame: Up to 5 years post-implant
Device Malfunctions
Number of device malfunctions reported
Time frame: Up to 5 years post-implant
Reoperations
Frequency and incidence of reoperations after initial implant surgery
Time frame: Up to 5 years post-implant
Rehospitalizations
Frequency and incidence of rehospitalizations after initial discharge from implant surgery
Time frame: Up to 5 years post-implant
| Milestone | Elevate Full Cohort |
|---|---|
| Started | 540 |
| Completed | 208 |
| Not completed | 332 |
| Withdrew: Death | 209 |
| Withdrew: Transplanted | 85 |
| Withdrew: Explanted | 8 |
| Withdrew: Device permanently deactivated | 4 |
| Withdrew: Implanted/exchanged to an lvad other than hm3 | 1 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Center did not participate in long-term fu | 4 |
| Withdrew: Refused consent to long-term fu | 13 |
Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
| Participants | Full Cohort |
|---|---|
| Survival | 293 |
EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).
| score on a scale | ELEVATE Patients |
|---|---|
| Baseline | 35 ± 20 |
| 1 Year | 67 ± 18 |
| 2 Years | 67 ± 20 |
| 3 Years | 66 ± 22 |
| 4 Years | 65 ± 22 |
| 5 Years | 64 ± 20 |
The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
| meters | ELEVATE Patients Horts |
|---|---|
| Baseline | 102.9 ± 139.5 |
| 1 Year | 370.7 ± 116.6 |
| 2 Years | 343.8 ± 127.3 |
| 3 Years | 356.7 ± 132.2 |
| 4 Years | 328.9 ± 137.7 |
| 5 Years | 301.2 ± 131.4 |
NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
| participants | ELEVATE Patients |
|---|---|
| Class I | 29 |
| Class II | 71 |
| Class III | 54 |
| Class IV | 3 |
Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)
| Participants | ELEVATE Patients |
|---|---|
| Arterial Non-CNS Thromboembolism | 10 |
| Cardiac Arrhythmias | 79 |
| Hemolysis | 2 |
| Hepatic Dysfunction | 12 |
| Hypertension | 12 |
| Major Bleeding | 155 |
| Major Infection | 258 |
| Myocardial Infarction | 3 |
| Neurologic Dysfunction | 73 |
| Pericardial Fluid Collection | 33 |
| Psychiatric Episode | 13 |
| Renal Dysfunction | 59 |
| Right Heart Failure | 70 |
| Venous Thromboembolism | 2 |
| Wound Dehiscence | 15 |
| Other Adverse Event/Adverse Device Effect | 219 |
Number of device malfunctions reported
| events | ELEVATE Patients |
|---|---|
| Thrombus: pump cover | 1 |
| Thrombus: inflow cannula (ingested) | 1 |
| Thrombus: outflow graft | 2 |
| Outflow graft bend relief disconnect | 1 |
| Outflow graft twist | 16 |
| Outflow graft kink | 1 |
| Dreiveline communication fault | 2 |
| Driveline damage - external | 14 |
| Driveline issue | 12 |
| Driveline disconnect causing pump stop | 3 |
| Driveline bend relief damage | 1 |
| Modular cable outer jacket tear | 1 |
| Controller issue | 1 |
Frequency and incidence of reoperations after initial implant surgery
| number of reoperation events | ELEVATE Patients |
|---|---|
| Reoperations | 774 |
Frequency and incidence of rehospitalizations after initial discharge from implant surgery
| number of rehospitalization events | ELEVATE Patients |
|---|---|
| Rehospitalizations | 1418 |
Collected over Up to 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ELEVATE Patients | 209/540 (38.7%) | 407/482 (84.4%) | 277/482 (57.5%) |
| Event | ELEVATE Patients |
|---|---|
| Major InfectionInfections and infestations | 258/482 |
| Other eventsGeneral disorders | 219/482 |
| Major BleedingBlood and lymphatic system disorders | 155/482 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 86/482 |
| Cardiac ArrhythmiasCardiac disorders | 79/482 |
| Neurologic DysfunctionNervous system disorders | 73/482 |
| Right Heart FailureCardiac disorders | 70/482 |
| Renal DysfunctionRenal and urinary disorders | 59/482 |
| Pericardial Fluid CollectionBlood and lymphatic system disorders | 33/482 |
| Wound DehiscenceSkin and subcutaneous tissue disorders | 15/482 |
| Event | ELEVATE Patients |
|---|---|
| Other Non Serious EventsGeneral disorders | 277/482 |
| Major InfectionInfections and infestations | 166/482 |
| Major BleedingBlood and lymphatic system disorders | 59/482 |
| Cardiac ArrhythmiasCardiac disorders | 53/482 |
| HypertensionBlood and lymphatic system disorders | 23/482 |
| Renal DysfunctionRenal and urinary disorders | 23/482 |
| Psychiatric EpisodePsychiatric disorders | 20/482 |
| Neurologic DysfunctionNervous system disorders | 19/482 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 17/482 |
| Right Heart FailureCardiac disorders | 9/482 |
Out of the 540 enrolled patients, baseline data were not collected for 58 subjects
| Age, Continuous(years) | ELEVATE Consented and Implanted Patients |
|---|---|
| Mean | 55.5 ± 11.7 |
| Sex: Female, Male(Participants) | ELEVATE Consented and Implanted Patients |
|---|---|
| Female | 53 |
| Male | 429 |
| Race (NIH/OMB)(Participants) | ELEVATE Consented and Implanted Patients |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 58 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 3 |
| White | 372 |
| More than one race | 0 |
| Unknown or Not Reported | 48 |
| Region of Enrollment(participants) | ELEVATE Consented and Implanted Patients |
|---|---|
| Austria | 20 |
| Netherlands | 28 |
| Singapore | 6 |
| Czechia | 24 |
| Denmark | 9 |
| Poland | 6 |
| United Kingdom | 45 |
| Italy | 15 |
| Israel | 13 |
| Kazakhstan | 54 |
| Germany | 262 |
| NYHA Class(Participants) | ELEVATE Consented and Implanted Patients |
|---|---|
| Class I | 5 |
| Class II | 2 |
| Class IIIA | 46 |
| Class IIIB | 169 |
| Class IV | 234 |
| Not provided | 26 |
| INTERMACS Profile(Participants) | ELEVATE Consented and Implanted Patients |
|---|---|
| 1 | 43 |
| 2 | 103 |
| 3 | 177 |
| 4 | 130 |
| 5 | 9 |
| 6 | 6 |
| 7 | 1 |
| Not provided | 13 |
| Indication(Participants) | ELEVATE Consented and Implanted Patients |
|---|---|
| Bridge to Transplant | 320 |
| Destination Therapy | 126 |
| Other Indication | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2015 to primary completion in Feb 2019, 40 months.
Results were first posted in Mar 2025, 6 years 1 month after primary completion.
Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's 40 months is above that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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