Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT04893603
Status:
RECRUITING
Last Update Posted:
2021-05-19
First Post:
2021-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
Sponsor:
Chengdu Silara Meditech Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation
Status:
RECRUITING
Status Verified Date:
2021-04
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:
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
Detailed Description:
Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study.
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?: