Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
1 other identifier
interventional
358
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2020
CompletedFirst Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2024
CompletedJuly 30, 2024
July 1, 2024
3.6 years
June 1, 2021
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Efficacy Endpoint: Number of participants with 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 will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. 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 be censored at that time in the analysis.
Throughout the study (approximately 4 years)
Primary Safety Endpoint: Number of cumulative occurrence of adverse events
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events and events per patient year of support.
Throughout the study (approximately 4 years)
Secondary Outcomes (6)
Mean change in Six-minute Walk Test from baseline
Through study completion, an average of 4 years
Change in proportion of New York Heart Association (NYHA) Functional Status from baseline
Through study completion, an average of 4 years
Mean change in EQ-5D-5L quality of life (QoL) from baseline
Through study completion, an average of 4 years
Frequency of Rehospitalization and Reoperation
Throughout the study (approximately 4 years)
Number of participants with Device Malfunctions
Throughout the study (approximately 4 years)
- +1 more secondary outcomes
Study Arms (1)
HeartMate 3™ left ventricular assist system (HM3 LVAS)
EXPERIMENTALPatients will be implanted with the HM3 LVAS
Interventions
Advanced heart failure patients will be implanted with the HM3 LVAS
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Incheon Sejong Hospital
Incheon, Nam-gu, 726, 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
Chonnam National University Hospital (CNUH)
Gwangju, 58128, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong, South Korea
Hallym University Sacred Heart Hospital
Hwaseong, South Korea
Seoul National University Hospital
Ihwa-dong, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
St. Mary's Hospital, The Catholic University of Eunpyeong
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Gazzola
Abbott
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 7, 2021
Study Start
October 30, 2020
Primary Completion
June 2, 2024
Study Completion
June 2, 2024
Last Updated
July 30, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share