Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
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Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
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
General Exclusion Criteria: This post market surveillance does not have specific exclusion criteria
Trial design
Primary purpose
Allocation
Interventional model
Masking
358 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Evonne Poon; Carlo Gazzola
Data sourced from clinicaltrials.gov
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