Clinical trial NCT00512005: VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study
Official title: Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mitral Valve Regurgitation
Left Ventricular Dysfunction
Heart Failure
Mitral Insufficiency
Mitral Incompetence
Ischemic Heart Disease
Keywords: Functional Mitral Regurgitation (FMR)
Ischemic Mitral Regurgitation
Less invasive repair
Percutaneous MV repair
Mitral Valve Repair
Heart Failure
Left Ventricular Dysfunction
Lead sponsor: Myocor
Sponsor class: INDUSTRY
First posted: 2007-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
timeFrame: Intra-procedure and peri-procedure
Secondary outcomes:
measure: Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes
timeFrame: 1, 3, 6, 12, 18, 24 months and annually thereafter
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare - Evanston Hospital
state: Illinois
city: Shawnee Mission
country: United States
facility: Shawnee Mission Hospital
state: Kansas
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
References: