Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03929913
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-15
First Post:
2019-04-26
Brief Title:
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
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:
None
Brief Summary:
This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation called transcatheter mitral valve cerclage annuloplasty otherwise known as cerclage Functional mitral valve regurgitation is a condition caused by damaged heart muscle involving the left ventricle which results in mitral valve leakage This leakage causes heart failure breathlessness and lack of energy especially when walking or exercising and hospital admissions for fluid buildup
This is an early feasibility study EFS evaluation of special devices permanently implanted in the heart to perform mitral cerclage annuloplasty Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery The cerclage devices compress the mitral valve like a purse-string The cerclage device has a special feature that prevents a coronary artery from getting squeezed as part of this purse-string
The protocol has been changed to allow patients who have mitral valve regurgitation despite prior Mitra-Clip treatment and to allow patients who have symptomatic heart failure with mild mitral regurgitation
This is an early feasibility study EFS evaluation of special devices permanently implanted in the heart to perform mitral cerclage annuloplasty Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery The cerclage devices compress the mitral valve like a purse-string The cerclage device has a special feature that prevents a coronary artery from getting squeezed as part of this purse-string
The protocol has been changed to allow patients who have mitral valve regurgitation despite prior Mitra-Clip treatment and to allow patients who have symptomatic heart failure with mild mitral regurgitation
Detailed Description:
Functional mitral regurgitation also known as secondary mitral regurgitation is a common complication of left ventricular dysfunction Ventricular dysfunction leads to dilation which in turn leads to mitral annular dilation and leaflet traction This causes a failure of coaptation of the otherwise intact leaflets of the mitral valve leading to regurgitation through a central orifice between the mal-coapting leaflet tips Functional mitral regurgitation contributes to heart failure symptoms Transcatheter Mitral Cerclage Annuloplasty TMCA is a new catheter technique that reduces the septal-lateral dimension of the dilated annulus through circumferential compression prevents extrinsic compression and entrapment of coronary arteries by incorporating a protection element and exhibits planar discordance that achieves annular reduction even when the coronary sinus is anatomically located along the posterior left atrial wall This is an entirely right-sided procedure and device
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19-H-0088 | None | None | None |