This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Percutaneous implantation of the Accucinch Implant in the mitral subannular space
The additive reduction in the mitral annular axial dimensions (anteroposterior plus commissure-to-commissure axes) measured via echocardiography, paired by subject
The differences between baseline and 6 months in the sum of the two annulus measures will be calculated for each subject and the mean change tested via the paired t-test.
Time frame: 6 months
Device Success: Percentage of patients in whom all pre-specified device performance endpoints are met but no pre-specified device complications are met.
Pre-specified endpoints are the following:stroke-free survival AND intended positioning of the original implant AND No additional surgical or interventional procedures AND intended performance of the device (no migration, embolization, fracture, thrombosis, etc AND reduction of MR by at least one grade and reduction of combined mitral annular diameters by at least 20%) AND no device-related complications (erosion, migration, etc.) at 30-days and all subsequent follow-up time points.
Time frame: 30 Days, 6 months, 12 months, and 2 years
Procedural Safety: Incidence rate of the occurrence of the individual pre-specified safety events that occur within 30 days of the index procedure
Pre-specified safety events include the following: * Death * Stroke * Life-threatening or Extensive bleeding (MVARC scale) * Major vascular complications * Major cardiac access (e.g., structural) complications * Stage 2 or 3 acute kidney injury (AKI) * New myocardial infarction or coronary insufficiency requiring PCI or CABG * Severe hypotension, heart failure, or respiratory failure * Any implant-related dysfunction or other complication requiring surgery or unplanned intervention or prolonged intubation \> 24 hours
Time frame: 30 days after the index procedure
Long Term Safety: Incidence rate of the occurrence of the individual pre-specified safety events at 6 months, 1 year, and 2 years.
Pre-specified endpoints include the following: * Death, cardiac, non-cardiac * Stroke * Mitral valve reintervention or surgery * MI * Any device related complication/ dysfunction * New atrial fibrillation (AF) * New conduction disturbance requiring permanent pacemaker (PM)
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Time frame: 6 months, 1 year, 2 years post index procedure