Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06034028
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-08-28
Brief Title:
J-Valve TF Early Feasibility Study
Sponsor:
JC Medical Inc
Organization:
JC Medical Inc
Study Overview
Official Title:
J-Valve TF Early Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
JVTF EFS
Brief Summary:
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement
Detailed Description:
The EFS is a prospective single arm multi-center interventional study that will enroll up to 15 subjects in up to 10 centers in the United States andor Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None