Trial Outcomes & Findings for HeartMate 3 ELEVATE™ Registry (NCT NCT02497950)
NCT ID: NCT02497950
Last Updated: 2025-03-20
Results Overview
Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
COMPLETED
540 participants
Up to 5 Years post-implant
2025-03-20
Participant Flow
The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
Participant milestones
| Measure |
Elevate Full Cohort
The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
|
|---|---|
|
Overall Study
STARTED
|
540
|
|
Overall Study
COMPLETED
|
208
|
|
Overall Study
NOT COMPLETED
|
332
|
Reasons for withdrawal
| Measure |
Elevate Full Cohort
The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
|
|---|---|
|
Overall Study
Death
|
209
|
|
Overall Study
Transplanted
|
85
|
|
Overall Study
Explanted
|
8
|
|
Overall Study
Device Permanently Deactivated
|
4
|
|
Overall Study
Implanted/Exchanged to an LVAD other than HM3
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Center Did Not Participate in Long-Term FU
|
4
|
|
Overall Study
Refused Consent to Long-Term FU
|
13
|
Baseline Characteristics
HeartMate 3 ELEVATE™ Registry
Baseline characteristics by cohort
| Measure |
ELEVATE Consented and Implanted Patients
n=482 Participants
Patients who received HM3 and provided informed consent
|
|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
429 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
372 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Kazakhstan
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
262 participants
n=5 Participants
|
|
NYHA Class
Class I
|
5 Participants
n=5 Participants
|
|
NYHA Class
Class II
|
2 Participants
n=5 Participants
|
|
NYHA Class
Class IIIA
|
46 Participants
n=5 Participants
|
|
NYHA Class
Class IIIB
|
169 Participants
n=5 Participants
|
|
NYHA Class
Class IV
|
234 Participants
n=5 Participants
|
|
NYHA Class
Not provided
|
26 Participants
n=5 Participants
|
|
INTERMACS Profile
1
|
43 Participants
n=5 Participants
|
|
INTERMACS Profile
2
|
103 Participants
n=5 Participants
|
|
INTERMACS Profile
3
|
177 Participants
n=5 Participants
|
|
INTERMACS Profile
4
|
130 Participants
n=5 Participants
|
|
INTERMACS Profile
5
|
9 Participants
n=5 Participants
|
|
INTERMACS Profile
6
|
6 Participants
n=5 Participants
|
|
INTERMACS Profile
7
|
1 Participants
n=5 Participants
|
|
INTERMACS Profile
Not provided
|
13 Participants
n=5 Participants
|
|
Indication
Bridge to Transplant
|
320 Participants
n=5 Participants
|
|
Indication
Destination Therapy
|
126 Participants
n=5 Participants
|
|
Indication
Other Indication
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 Years post-implantPopulation: The ELEVATE Study included 540 subjects of which: 482 received HM3 and provided informed consent, while 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
Outcome measures
| Measure |
Full Cohort
n=540 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
Survival
|
293 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVASPopulation: Out of 540 enrolled patients, secondary outcome data were not collected for 58 patients
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).
Outcome measures
| Measure |
Full Cohort
n=482 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
EuroQoL-5D-5L (EQ-5D-5L) VAS
Baseline
|
35 score on a scale
Standard Deviation 20
|
|
EuroQoL-5D-5L (EQ-5D-5L) VAS
1 Year
|
67 score on a scale
Standard Deviation 18
|
|
EuroQoL-5D-5L (EQ-5D-5L) VAS
2 Years
|
67 score on a scale
Standard Deviation 20
|
|
EuroQoL-5D-5L (EQ-5D-5L) VAS
3 Years
|
66 score on a scale
Standard Deviation 22
|
|
EuroQoL-5D-5L (EQ-5D-5L) VAS
4 Years
|
65 score on a scale
Standard Deviation 22
|
|
EuroQoL-5D-5L (EQ-5D-5L) VAS
5 Years
|
64 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: At 5 years after implantPopulation: The test was collected only if performed as per center's Standard of Care.
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.
Outcome measures
| Measure |
Full Cohort
n=482 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
Six Minute Walk Test (6MWT)
1 Year
|
370.7 meters
Standard Deviation 116.6
|
|
Six Minute Walk Test (6MWT)
2 Years
|
343.8 meters
Standard Deviation 127.3
|
|
Six Minute Walk Test (6MWT)
3 Years
|
356.7 meters
Standard Deviation 132.2
|
|
Six Minute Walk Test (6MWT)
Baseline
|
102.9 meters
Standard Deviation 139.5
|
|
Six Minute Walk Test (6MWT)
4 Years
|
328.9 meters
Standard Deviation 137.7
|
|
Six Minute Walk Test (6MWT)
5 Years
|
301.2 meters
Standard Deviation 131.4
|
SECONDARY outcome
Timeframe: At 5 years after implantPopulation: Patients who received HM3 as either a primary implant and patients who received the HM3 or a replacement of another durable LVAD
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
Outcome measures
| Measure |
Full Cohort
n=482 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
New York Heart Association (NYHA) Classification
Class I
|
29 participants
|
|
New York Heart Association (NYHA) Classification
Class II
|
71 participants
|
|
New York Heart Association (NYHA) Classification
Class III
|
54 participants
|
|
New York Heart Association (NYHA) Classification
Class IV
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 5 years post-implantPopulation: The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)
Outcome measures
| Measure |
Full Cohort
n=482 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
Adverse Events
Renal Dysfunction
|
59 Participants
|
|
Adverse Events
Right Heart Failure
|
70 Participants
|
|
Adverse Events
Venous Thromboembolism
|
2 Participants
|
|
Adverse Events
Wound Dehiscence
|
15 Participants
|
|
Adverse Events
Other Adverse Event/Adverse Device Effect
|
219 Participants
|
|
Adverse Events
Arterial Non-CNS Thromboembolism
|
10 Participants
|
|
Adverse Events
Cardiac Arrhythmias
|
79 Participants
|
|
Adverse Events
Hemolysis
|
2 Participants
|
|
Adverse Events
Hepatic Dysfunction
|
12 Participants
|
|
Adverse Events
Hypertension
|
12 Participants
|
|
Adverse Events
Major Bleeding
|
155 Participants
|
|
Adverse Events
Major Infection
|
258 Participants
|
|
Adverse Events
Myocardial Infarction
|
3 Participants
|
|
Adverse Events
Neurologic Dysfunction
|
73 Participants
|
|
Adverse Events
Pericardial Fluid Collection
|
33 Participants
|
|
Adverse Events
Psychiatric Episode
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post-implantPopulation: The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
Number of device malfunctions reported
Outcome measures
| Measure |
Full Cohort
n=482 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
Device Malfunctions
Thrombus: pump cover
|
1 events
|
|
Device Malfunctions
Dreiveline communication fault
|
2 events
|
|
Device Malfunctions
Driveline damage - external
|
14 events
|
|
Device Malfunctions
Driveline issue
|
12 events
|
|
Device Malfunctions
Driveline disconnect causing pump stop
|
3 events
|
|
Device Malfunctions
Driveline bend relief damage
|
1 events
|
|
Device Malfunctions
Modular cable outer jacket tear
|
1 events
|
|
Device Malfunctions
Controller issue
|
1 events
|
|
Device Malfunctions
Thrombus: inflow cannula (ingested)
|
1 events
|
|
Device Malfunctions
Thrombus: outflow graft
|
2 events
|
|
Device Malfunctions
Outflow graft bend relief disconnect
|
1 events
|
|
Device Malfunctions
Outflow graft twist
|
16 events
|
|
Device Malfunctions
Outflow graft kink
|
1 events
|
SECONDARY outcome
Timeframe: Up to 5 years post-implantPopulation: The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
Frequency and incidence of reoperations after initial implant surgery
Outcome measures
| Measure |
Full Cohort
n=482 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
Reoperations
|
774 number of reoperation events
|
SECONDARY outcome
Timeframe: Up to 5 years post-implantPopulation: The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
Frequency and incidence of rehospitalizations after initial discharge from implant surgery
Outcome measures
| Measure |
Full Cohort
n=482 Participants
The ELEVATE Full Cohort includes 540 subjects of which:
482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome
|
|---|---|
|
Rehospitalizations
|
1418 number of rehospitalization events
|
Adverse Events
ELEVATE Patients
Serious adverse events
| Measure |
ELEVATE Patients
n=482 participants at risk
The ELEVATE study included 540 subjects of which: 463 pts received HM3 as primary implant and 19 pts received the HM3 as a replacement of another durable LVAD. These 2 groups ( 482 pts) consist the main study population, for which complete information has been collected. In addition, 58 patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
|
|---|---|
|
Cardiac disorders
Arterial Non-CNS Thromboembolism
|
2.1%
10/482 • Number of events 11 • Up to 5 years
|
|
Cardiac disorders
Cardiac Arrhythmias
|
16.4%
79/482 • Number of events 112 • Up to 5 years
|
|
Hepatobiliary disorders
Hemolysis
|
0.41%
2/482 • Number of events 9 • Up to 5 years
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
2.5%
12/482 • Number of events 12 • Up to 5 years
|
|
Blood and lymphatic system disorders
Major Bleeding
|
32.2%
155/482 • Number of events 281 • Up to 5 years
|
|
Infections and infestations
Major Infection
|
53.5%
258/482 • Number of events 552 • Up to 5 years
|
|
Cardiac disorders
Myocardial Infarction
|
0.62%
3/482 • Number of events 3 • Up to 5 years
|
|
Nervous system disorders
Neurologic Dysfunction
|
15.1%
73/482 • Number of events 86 • Up to 5 years
|
|
Blood and lymphatic system disorders
Pericardial Fluid Collection
|
6.8%
33/482 • Number of events 38 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric Episode
|
2.7%
13/482 • Number of events 14 • Up to 5 years
|
|
Renal and urinary disorders
Renal Dysfunction
|
12.2%
59/482 • Number of events 69 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
17.8%
86/482 • Number of events 95 • Up to 5 years
|
|
Cardiac disorders
Right Heart Failure
|
14.5%
70/482 • Number of events 80 • Up to 5 years
|
|
Blood and lymphatic system disorders
Venous Thromboembolism
|
0.41%
2/482 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
3.1%
15/482 • Number of events 15 • Up to 5 years
|
|
General disorders
Other events
|
45.4%
219/482 • Number of events 473 • Up to 5 years
|
Other adverse events
| Measure |
ELEVATE Patients
n=482 participants at risk
The ELEVATE study included 540 subjects of which: 463 pts received HM3 as primary implant and 19 pts received the HM3 as a replacement of another durable LVAD. These 2 groups ( 482 pts) consist the main study population, for which complete information has been collected. In addition, 58 patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
|
|---|---|
|
Cardiac disorders
Cardiac Arrhythmias
|
11.0%
53/482 • Number of events 69 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.41%
2/482 • Number of events 2 • Up to 5 years
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
1.7%
8/482 • Number of events 9 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hypertension
|
4.8%
23/482 • Number of events 24 • Up to 5 years
|
|
Blood and lymphatic system disorders
Major Bleeding
|
12.2%
59/482 • Number of events 90 • Up to 5 years
|
|
Infections and infestations
Major Infection
|
34.4%
166/482 • Number of events 262 • Up to 5 years
|
|
Nervous system disorders
Neurologic Dysfunction
|
3.9%
19/482 • Number of events 20 • Up to 5 years
|
|
Blood and lymphatic system disorders
Pericardial Fluid Collection
|
0.62%
3/482 • Number of events 3 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric Episode
|
4.1%
20/482 • Number of events 20 • Up to 5 years
|
|
Renal and urinary disorders
Renal Dysfunction
|
4.8%
23/482 • Number of events 27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.5%
17/482 • Number of events 20 • Up to 5 years
|
|
Cardiac disorders
Right Heart Failure
|
1.9%
9/482 • Number of events 9 • Up to 5 years
|
|
Blood and lymphatic system disorders
Venous Thromboembolism
|
0.21%
1/482 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
0.83%
4/482 • Number of events 5 • Up to 5 years
|
|
General disorders
Other Non Serious Events
|
57.5%
277/482 • Number of events 826 • Up to 5 years
|
Additional Information
Prof. Finn Gustafsson
Rigshospitalet Copenhagen, Denmark
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60