Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455787
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
J-Valve Transfemoral Pivotal Study
Sponsor:
JC Medical Inc
Organization:
JC Medical Inc
Study Overview
Official Title:
J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
JOURNEY
Brief Summary:
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral TF System in patients with symptomatic severe grade 3 or 4 native aortic valve regurgitation AR and AR-dominant mixed aortic valve disease who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement SAVR
Detailed Description:
This is a prospective single arm multi-center interventional pivotal study that will enroll up to 171 subjects in up to 25 investigational sites in the United States and Canada The subjects will then be followed 5-years post-procedure of the J-Valve TF System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None