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Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (Korea HM3 PMS)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Chonnam National University Hospital (CNUH)
Gwangju, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong, South Korea
Start Date
October 30, 2020
Primary Completion Date
June 2, 2024
Completion Date
June 2, 2024
Last Updated
July 30, 2024
358
ACTUAL participants
HeartMate 3™ left ventricular assist system (HM3 LVAS)
DEVICE
Lead Sponsor
Abbott Medical Devices
NCT06228209
NCT04475393
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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