Advanced Heart Failure
Conditions
Keywords
HeartMate 3, ABT-CIP-10344, Left ventricular assist device
Brief summary
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll up to 300 patients, that meet the Health Insurance Review and Assessment (HIRA) guidelines for LVAD implantation, from up to 25 sites in South Korea. Subjects who will be implanted but not included in the PMS can be enrolled retrospectively after obtaining their informed consent. The surveillance period for this PMS is expected to be 4 years from the time of HM3 approval in Korea, concluding on June 2, 2024.
Interventions
Advanced heart failure patients will be implanted with the HM3 LVAS
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: All patients approved for HM3 implantation in Korea as per HIRA guidelines will be eligible to be enrolled in the PMS. Only the patients who provide written informed consent will be included in the study. If a subject has had an outcome after the HM3 implantation but prior to providing informed consent, no consent will be obtained, and a limited anonymized data will be collected.
Exclusion criteria
This post market surveillance does not have specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Kaplan-Meier Success Rate of Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (60 Days Post-stroke Modified Rankin Score >3) or Reoperation for Pump Replacement | From enrollment to 36 months | Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (60 days post-stroke Modified Rankin Score \>3) or reoperation for pump replacement. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will not be considered to have experienced a primary endpoint event. |
| Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events | From enrollment until the study conclusion date (up to 43 months, 3 days) | Cumulative occurrence of adverse events will be presented as percent of patients with adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute Walk Test Distance | Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant | The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging. |
| New York Heart Association (NYHA) Functional Status | Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant | 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 fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort. |
| EQ-5D-5L Quality-of-Life Visual Analog Scale | Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months Post-Implant | Subject's quality-of-life (QoL) will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after HM3 implant until the end of surveillance period. The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life. The overall mean and standard deviation of the Visual Analog Scale (VAS) will be presented for all follow-up visits. The VAS is not available for all participants at all follow up timepoints. |
| Frequency of Rehospitalization | From enrollment until the study conclusion date (up to 43 months, 3 days) | Frequency of rehospitalization events inclusive of rehospitalization for heart transplantation. |
| Frequency of Reoperation | From enrollment until the study conclusion date (up to 43 months, 3 days) | Number of reoperation events inclusive of heart transplantations. |
| Device Malfunctions | From enrollment until the study conclusion date (up to 43 months, 3 days) | All suspected HM3 device malfunctions will be reported. Device malfunctions will be collected under the general category of Device Deficiencies. Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate labeling. This includes the failure of the device to meet its performance specifications or otherwise perform as intended. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORCarlo Gazzola
Abbott
Participant flow
Recruitment details
The Korea HM3 Post Market Surveillance enrolled patients implanted from October 30, 2020 - 02 June 2024. The study enrolled 358 subjects at 18 investigational sites in Korea.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.3 Years STANDARD_DEVIATION 14.3 |
| Body Mass Index | 23.9 kg/m^2 STANDARD_DEVIATION 11.5 |
| Intended Use Bridge to Recovery | 0 Participants |
| Intended Use Bridge to Transplant (BTT) | 263 Participants |
| Intended Use Destination Therapy | 52 Participants |
| Intended Use Possibly BTT: Likely to be Eligible | 10 Participants |
| Intended Use Possibly BTT: Moderate Likelihood | 1 Participants |
| Intended Use Possibly BTT: Unlikely to Become Eligible | 1 Participants |
| Intended Use Rescue Therapy | 0 Participants |
| INTERMACS Profile 1 | 25 Participants |
| INTERMACS Profile 2 | 51 Participants |
| INTERMACS Profile 3 | 217 Participants |
| INTERMACS Profile 4 | 22 Participants |
| INTERMACS Profile 5 | 2 Participants |
| INTERMACS Profile 6 or 7 | 4 Participants |
| New York Heart Association (NYHA) Class Class I | 0 Participants |
| New York Heart Association (NYHA) Class Class II | 25 Participants |
| New York Heart Association (NYHA) Class Class IIIA | 55 Participants |
| New York Heart Association (NYHA) Class Class IIIB | 49 Participants |
| New York Heart Association (NYHA) Class Class IV | 197 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 327 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Korea | 327 Participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 51 / 358 |
| other Total, other adverse events | 8 / 327 |
| serious Total, serious adverse events | 154 / 327 |
Outcome results
None listed