Status:
COMPLETED
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
Lead Sponsor:
Abbott Medical Devices
Conditions:
Advanced Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 advance...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- General 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
- This post market surveillance does not have specific exclusion criteria
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2024
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT04915924
Start Date
October 30 2020
End Date
June 2 2024
Last Update
July 30 2024
Active Locations (22)
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1
Incheon Sejong Hospital
Incheon, Nam-gu, South Korea, 726
2
Korea University Ansan Hospital
Ansan, South Korea
3
Sejong Hospital
Bucheon-si, South Korea
4
Pusan National University Hospital
Busan, South Korea