Ignite Creation Date:
2025-12-18 @ 9:33 AM
Ignite Modification Date:
2025-12-23 @ 9:03 PM
Study NCT ID:
NCT03567278
Status:
None
Last Update Posted:
2018-06-25 00:00:00
First Post:
2014-12-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)
Sponsor:
None
Organization:
Study Overview
Official Title:
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis
Status:
None
Status Verified Date:
2018-05
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:
TA-FIM
Brief Summary:
A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating the feasibility and performance of the implantation and the safety at 30-Day follow-up.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: