A Phase 1 interventional study of Percutaneous mitral valve repair in Mitral Valve Regurgitation, Left Ventricular Dysfunction and Heart Failure, sponsored by Myocor. Status unknown at 4 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-06-24.
Sponsored by Myocor · Phase 1, Interventional, and Treatment
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 and/or papillary muscle displacement.
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.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Myocor is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Ventricular reshaping to treat functional mitral insufficiency
Also known as: iCoapsys System
Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
Time frame: Intra-procedure and peri-procedure
Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes
Time frame: 1, 3, 6, 12, 18, 24 months and annually thereafter
This study is status unknown, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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