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Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
Sponsor: Abbott Medical Devices
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.
Official title: Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (Korea HM3 PMS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
358
Start Date
2020-10-30
Completion Date
2024-06-02
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
HeartMate 3™ left ventricular assist system (HM3 LVAS)
Advanced heart failure patients will be implanted with the HM3 LVAS
Locations (22)
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
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