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

Sponsor

Myocor (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00512005

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Regurgitation Left Ventricular Dysfunction Heart Failure Mitral Insufficiency Mitral Incompetence Ischemic Heart Disease	Device: Percutaneous mitral valve repair	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2013

Outcome Measures

Primary Outcome Measures

Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System [Intra-procedure and peri-procedure]

Secondary Outcome Measures

Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes [1, 3, 6, 12, 18, 24 months and annually thereafter]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital	Atlanta	Georgia	United States	30322
2	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois	United States	60201
3	Shawnee Mission Hospital	Shawnee Mission	Kansas	United States	66204
4	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55440