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Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea

Advanced Heart Failure Clinical Trial

Official title:
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (Korea HM3 PMS)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04915924
Study type Interventional
Source Abbott Medical Devices
Contact Evonne Poon
Phone +65 69148433
Email evonnesueyin.poon@abbott.com
Status Recruiting
Phase N/A
Start date October 30, 2020
Completion date December 31, 2024
View Details
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