Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
NCT: NCT04915924 · COMPLETED
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.
Frequently Asked Questions
What is Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea?
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea is a clinical trial registered under NCT04915924. Current status: COMPLETED.
What is the status of NCT04915924?
The current status of NCT04915924 (Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea) is: COMPLETED.
When did Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea start?
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea started on 2020-10-30.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.