Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583876
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Bio Refine for Functional Mitral Regurgitation - a Safety Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bio Refine for Functional Mitral Regurgitation - a Safety Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation
The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot andor will not be offered as a treatment option the risk is prohibitive
Potential patients will be screened to confirm that all inclusionexclusion criteria are met with final eligibility confirmation on day of procedure
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge
Additional follow up time points are scheduled at 30 days 6 months and 12 months post procedure
The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot andor will not be offered as a treatment option the risk is prohibitive
Potential patients will be screened to confirm that all inclusionexclusion criteria are met with final eligibility confirmation on day of procedure
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge
Additional follow up time points are scheduled at 30 days 6 months and 12 months post procedure
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?:
None