Heart Failure, Ischemic Heart Disease, Left Ventricular Dysfunction, Mitral Incompetence, Mitral Insufficiency, Mitral Valve Regurgitation
Conditions
Keywords
Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Percutaneous MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction
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.
Interventions
Ventricular reshaping to treat functional mitral insufficiency
Sponsors
Myocor
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes | 1, 3, 6, 12, 18, 24 months and annually thereafter |
Countries
United States
Contacts
Primary ContactCyril J. Schweich, MD
Backup ContactAdam K Hoyhtya, MS
Outcome results
None listed