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

Myocor

Status and phase

Unknown

Phase 1

Conditions

Mitral Incompetence

Ischemic Heart Disease

Mitral Valve Regurgitation

Mitral Insufficiency

Heart Failure

Left Ventricular Dysfunction

Treatments

Device: Percutaneous mitral valve repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT00512005

030301

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%

Key Exclusion Criteria:

History of pericarditis.
Creatinine > 2.2 at the time of the procedure
INR > 1.8 at the time of the procedure
Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
Structural abnormality of the mitral valve
Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
Pericardial effusion >5 mm via echocardiography.
Posterior wall end-diastolic dimension >1.3 cm.
Left ventricular end diastolic diameter > 7.0 cm.