Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT05607667
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2022-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial in China for Aortic Valve Stenosis
Sponsor:
Genesis Medtech Corporation
Organization:
Study Overview
Official Title:
Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Stenosis Disease
Status:
COMPLETED
Status Verified Date:
2025-07
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:
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.
Detailed Description:
This study is a prospective, multicenter, single-arm, clinical study.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: