Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-02 @ 9:18 AM
Study NCT ID:
NCT05330468
Status:
COMPLETED
Last Update Posted:
2025-10-27
First Post:
2022-04-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Regent China Post-Market Clinical Follow-up Study
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Regent China Post-Market Clinical Follow-up Study
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: