Regent China Post-Market Clinical Follow-up Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05330468
Study type	Observational
Source	Abbott Medical Devices
Contact
Status	Active, not recruiting
Phase
Start date	March 29, 2022
Completion date	August 31, 2028

View Details

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