Heart Failure Clinical Trial
Official title:
Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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