Regent China Post-Market Clinical Follow-up Study
NCT05330468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2025-10-27
Summary
Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.
Conditions
- Valvular Heart Disease
- Aortic Valve Disease
Interventions
- DEVICE
-
Abbott Mechanical Heart Valve (MHV) Regent™
SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Kyle Brunner · Abbott
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-29
- Primary Completion
- 2024-10-10
- Completion
- 2024-10-10
Countries
- China
Study Locations
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