Cardiovascular Disease, Heart Failure, Ventricular Dysfunction
Conditions
Keywords
HeartMate 3, LVAS, LVAD, Heart-assist devices, Thoratec Corporation
Brief summary
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
Detailed description
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.
Interventions
DEVICEHeartMate 3
Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3
Sponsors
Thoratec Europe Ltd
Thoratec Corporation
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. Patient consented to registry data collection 2. Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Up to 5 Years post-implant | Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test (6MWT) | At 5 years after implant | 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. |
| New York Heart Association (NYHA) Classification | At 5 years after implant | 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 |
| Adverse Events | Up to 5 years post-implant | Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges) |
| EuroQoL-5D-5L (EQ-5D-5L) VAS | Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS | 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). |
| Reoperations | Up to 5 years post-implant | Frequency and incidence of reoperations after initial implant surgery |
| Rehospitalizations | Up to 5 years post-implant | Frequency and incidence of rehospitalizations after initial discharge from implant surgery |
| Device Malfunctions | Up to 5 years post-implant | Number of device malfunctions reported |
Countries
Austria, Czechia, Denmark, Germany, Israel, Italy, Kazakhstan, Netherlands, Poland, Singapore, United Kingdom
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| ELEVATE Consented and Implanted Patients Patients who received HM3 and provided informed consent | 482 |
| Total | 482 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Center Did Not Participate in Long-Term FU | 4 |
| Overall Study | Death | 209 |
| Overall Study | Device Permanently Deactivated | 4 |
| Overall Study | Explanted | 8 |
| Overall Study | Implanted/Exchanged to an LVAD other than HM3 | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Refused Consent to Long-Term FU | 13 |
| Overall Study | Transplanted | 85 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | ELEVATE Consented and Implanted Patients |
|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 11.7 |
| Indication Bridge to Transplant | 320 Participants |
| Indication Destination Therapy | 126 Participants |
| Indication Other Indication | 36 Participants |
| INTERMACS Profile 1 | 43 Participants |
| INTERMACS Profile 2 | 103 Participants |
| INTERMACS Profile 3 | 177 Participants |
| INTERMACS Profile 4 | 130 Participants |
| INTERMACS Profile 5 | 9 Participants |
| INTERMACS Profile 6 | 6 Participants |
| INTERMACS Profile 7 | 1 Participants |
| INTERMACS Profile Not provided | 13 Participants |
| NYHA Class Class I | 5 Participants |
| NYHA Class Class II | 2 Participants |
| NYHA Class Class IIIA | 46 Participants |
| NYHA Class Class IIIB | 169 Participants |
| NYHA Class Class IV | 234 Participants |
| NYHA Class Not provided | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 58 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 48 Participants |
| Race (NIH/OMB) White | 372 Participants |
| Region of Enrollment Austria | 20 participants |
| Region of Enrollment Czechia | 24 participants |
| Region of Enrollment Denmark | 9 participants |
| Region of Enrollment Germany | 262 participants |
| Region of Enrollment Israel | 13 participants |
| Region of Enrollment Italy | 15 participants |
| Region of Enrollment Kazakhstan | 54 participants |
| Region of Enrollment Netherlands | 28 participants |
| Region of Enrollment Poland | 6 participants |
| Region of Enrollment Singapore | 6 participants |
| Region of Enrollment United Kingdom | 45 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 429 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 209 / 540 |
| other Total, other adverse events | 277 / 482 |
| serious Total, serious adverse events | 407 / 482 |
Outcome results
Primary
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
Population: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Cohort | Survival | 293 Participants |
Secondary
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
Population: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Cohort | Adverse Events | Arterial Non-CNS Thromboembolism | 10 Participants |
| Full Cohort | Adverse Events | Cardiac Arrhythmias | 79 Participants |
| Full Cohort | Adverse Events | Hemolysis | 2 Participants |
| Full Cohort | Adverse Events | Hepatic Dysfunction | 12 Participants |
| Full Cohort | Adverse Events | Hypertension | 12 Participants |
| Full Cohort | Adverse Events | Major Bleeding | 155 Participants |
| Full Cohort | Adverse Events | Major Infection | 258 Participants |
| Full Cohort | Adverse Events | Myocardial Infarction | 3 Participants |
| Full Cohort | Adverse Events | Neurologic Dysfunction | 73 Participants |
| Full Cohort | Adverse Events | Pericardial Fluid Collection | 33 Participants |
| Full Cohort | Adverse Events | Psychiatric Episode | 13 Participants |
| Full Cohort | Adverse Events | Right Heart Failure | 70 Participants |
| Full Cohort | Adverse Events | Venous Thromboembolism | 2 Participants |
| Full Cohort | Adverse Events | Wound Dehiscence | 15 Participants |
| Full Cohort | Adverse Events | Other Adverse Event/Adverse Device Effect | 219 Participants |
| Full Cohort | Adverse Events | Renal Dysfunction | 59 Participants |
Secondary
Device Malfunctions
Number of device malfunctions reported
Time frame: Up to 5 years post-implant
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Cohort | Device Malfunctions | Thrombus: pump cover | 1 events |
| Full Cohort | Device Malfunctions | Thrombus: inflow cannula (ingested) | 1 events |
| Full Cohort | Device Malfunctions | Thrombus: outflow graft | 2 events |
| Full Cohort | Device Malfunctions | Outflow graft bend relief disconnect | 1 events |
| Full Cohort | Device Malfunctions | Outflow graft twist | 16 events |
| Full Cohort | Device Malfunctions | Outflow graft kink | 1 events |
| Full Cohort | Device Malfunctions | Dreiveline communication fault | 2 events |
| Full Cohort | Device Malfunctions | Driveline damage - external | 14 events |
| Full Cohort | Device Malfunctions | Driveline issue | 12 events |
| Full Cohort | Device Malfunctions | Driveline bend relief damage | 1 events |
| Full Cohort | Device Malfunctions | Modular cable outer jacket tear | 1 events |
| Full Cohort | Device Malfunctions | Controller issue | 1 events |
| Full Cohort | Device Malfunctions | Driveline disconnect causing pump stop | 3 events |
Secondary
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
Population: Out of 540 enrolled patients, secondary outcome data were not collected for 58 patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Cohort | EuroQoL-5D-5L (EQ-5D-5L) VAS | Baseline | 35 score on a scale | Standard Deviation 20 |
| Full Cohort | EuroQoL-5D-5L (EQ-5D-5L) VAS | 1 Year | 67 score on a scale | Standard Deviation 18 |
| Full Cohort | EuroQoL-5D-5L (EQ-5D-5L) VAS | 2 Years | 67 score on a scale | Standard Deviation 20 |
| Full Cohort | EuroQoL-5D-5L (EQ-5D-5L) VAS | 3 Years | 66 score on a scale | Standard Deviation 22 |
| Full Cohort | EuroQoL-5D-5L (EQ-5D-5L) VAS | 4 Years | 65 score on a scale | Standard Deviation 22 |
| Full Cohort | EuroQoL-5D-5L (EQ-5D-5L) VAS | 5 Years | 64 score on a scale | Standard Deviation 20 |
Secondary
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
Population: Patients who received HM3 as either a primary implant and patients who received the HM3 or a replacement of another durable LVAD
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Cohort | New York Heart Association (NYHA) Classification | Class I | 29 participants |
| Full Cohort | New York Heart Association (NYHA) Classification | Class II | 71 participants |
| Full Cohort | New York Heart Association (NYHA) Classification | Class III | 54 participants |
| Full Cohort | New York Heart Association (NYHA) Classification | Class IV | 3 participants |
Secondary
Rehospitalizations
Frequency and incidence of rehospitalizations after initial discharge from implant surgery
Time frame: Up to 5 years post-implant
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Cohort | Rehospitalizations | 1418 number of rehospitalization events |
Secondary
Reoperations
Frequency and incidence of reoperations after initial implant surgery
Time frame: Up to 5 years post-implant
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Cohort | Reoperations | 774 number of reoperation events |
Secondary
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
Population: The test was collected only if performed as per center's Standard of Care.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Cohort | Six Minute Walk Test (6MWT) | 4 Years | 328.9 meters | Standard Deviation 137.7 |
| Full Cohort | Six Minute Walk Test (6MWT) | 5 Years | 301.2 meters | Standard Deviation 131.4 |
| Full Cohort | Six Minute Walk Test (6MWT) | Baseline | 102.9 meters | Standard Deviation 139.5 |
| Full Cohort | Six Minute Walk Test (6MWT) | 1 Year | 370.7 meters | Standard Deviation 116.6 |
| Full Cohort | Six Minute Walk Test (6MWT) | 2 Years | 343.8 meters | Standard Deviation 127.3 |
| Full Cohort | Six Minute Walk Test (6MWT) | 3 Years | 356.7 meters | Standard Deviation 132.2 |