NCT00512005

VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study

Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Myocor · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 and/or 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.

Conditions

• Mitral Valve Regurgitation
• Left Ventricular Dysfunction
• Heart Failure
• Mitral Insufficiency
• Mitral Incompetence
• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous mitral valve repair	Ventricular reshaping to treat functional mitral insufficiency

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-12-01
• Completion: 2013-12-01
• First posted: 2007-08-07
• Last updated: 2009-06-24

Locations

4 sites across 1 country: United States