Overview
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.
Eligibility
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