Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512005
Status:
UNKNOWN
Last Update Posted:
2009-06-24
First Post:
2007-08-06
Brief Title:
VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study
Sponsor:
Myocor
Organization:
Myocor
Study Overview
Official Title:
Valvular and Ventricular Improvement Via iCoapsys Delivery VIVID Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
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:
VIVID
Brief Summary:
The purpose of this prospective non-randomized single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation andor papillary muscle displacement
Detailed Description:
Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy Patients with functional MR generally have normal valvular structures complicated by left ventricular dysfunction Left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation rendering the valve incompetent Changes that will induce functional MR may include i dyskinetic or akinetic wall segments ii dilation of the valve annulus or iii dilation of the left ventricle leading to tethering of the chordae tendinae
The iCoapsys Device is intended to treat patients with functional MR The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever degenerative diseases endocarditis infiltrative diseases or congenital disorders
The iCoapsys Device is intended to treat patients with functional MR The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever degenerative diseases endocarditis infiltrative diseases or congenital disorders
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