VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Percutaneous mitral valve repair

Ventricular reshaping to treat functional mitral insufficiency

Intervention Type DEVICE

Other Intervention Names

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iCoapsys System

Eligibility Criteria

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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%

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No