NCT05330468

Regent China Post-Market Clinical Follow-up Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the RC-PMCF study is to meet the post-market clinical followup (PMCF) requirements of the National Medical Products Administration (NMPA). The primary objective of 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. This is a prospective, observational, multi-center study of subjects clinically indicated for implantation of an Abbott Medical's Regent Valve.

Conditions

• Valvular Heart Disease
• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Abbott Mechanical Heart Valve (MHV) Regent™	SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)

Timeline

• Start date: 2022-03-29
• Primary completion: 2024-10-10
• Completion: 2024-10-10
• First posted: 2022-04-15
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

5 sites across 1 country: China