Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 8
- Primary Endpoint
- Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
Time Frame: Intra-procedure and peri-procedure
Secondary Outcomes
- Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes(1, 3, 6, 12, 18, 24 months and annually thereafter)