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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
358
Advanced heart failure patients will be implanted with the HM3 LVAS
Chonnam National University Hospital (CNUH)
Gwangju, Gwangju, South Korea
Incheon Sejong Hospital
Incheon, Nam-gu, South Korea
Korea University Ansan Hospital
Ansan, South Korea
Sejong Hospital
Bucheon-si, South Korea
Pusan National University Hospital
Busan, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong, South Korea
...and 12 more locations
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
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.
Time frame: From enrollment to 36 months
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events.
Time frame: From enrollment until the study conclusion date (up to 43 months, 3 days)
Six-minute Walk Test Distance
The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant
New York Heart Association (NYHA) Functional Status
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.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant
EQ-5D-5L Quality-of-Life Visual Analog Scale
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.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months Post-Implant
Frequency of Rehospitalization
Frequency of rehospitalization events inclusive of rehospitalization for heart transplantation.
Time frame: From enrollment until the study conclusion date (up to 43 months, 3 days)
Frequency of Reoperation
Number of reoperation events inclusive of heart transplantations.
Time frame: From enrollment until the study conclusion date (up to 43 months, 3 days)
Device Malfunctions
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.
Time frame: From enrollment until the study conclusion date (up to 43 months, 3 days)
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