To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Percutaneous Coronary Intervention
Monash Health
Melbourne, Victoria, Australia
Procedural Success
Successful use and implantation of an Accucinch System without Major Adverse Events (MAE) defined as the occurrence of any of the following: All-cause mortality, Device and/or procedure-related death; Peri-procedural myocardial infarction (MI) \< or equal to 72 hrs after index procedure; Major stroke; Urgent or emergent conversion to surgery or repeat procedure (surgical or interventional therapy) for mitral valve or heart failure related deterioration; Left ventricular perforation; Major vascular complications; Major bleeding (including cardiac tamponade)
Time frame: 72 hours post-procedure
Device Success
Successful vascular access, delivery, and retrieval of the delivery system; Ability to establish access to the sub-annular groove, to deploy the Anchors, and the Anchor Links, to apply tension to the Cinch Cable, to reshape the mitral annulus, to deploy the Lock, and to cut the Cinch Cable; Intended performance of the Accucinch System measured by TTE acutely post-cinch with a reduction of MR by at least one grade
Time frame: 24 hours post-procedure
Clinical Safety Measures
Defined as freedom from MAE at discharge or 7 days post-procedure, whichever comes first; Safety measures will be reviewed and adjudicated by an independent clinical events committee (CEC); Echocardiographic measures will be assessed by an independent echocardiography core laboratory
Time frame: 7 day post procedure
Clinical Measure
NYHA Class improvement of at lease one score from baseline
Time frame: 30 day post-procedure
Echocardiographic Measures - Composite
Mitral Valve Measures: One grade reduction in MR (e.g. 3+ to 2+), or; Reduction in PISA EROA at least 25% from baseline, or; Reduction in Regurgitant Volume at least 25% Left Ventricular Measures: Reduction in Left Ventricular size (Left Ventricular End Diastolic Dimension - LVEDD) at least 5% from baseline, or: Reduction in Left Ventricular volume (Left Ventricular End Diastolic Volume -LVEDV) at least 5%, or Increase in ejection fraction (LVEF) at least 10% from baseline Left Atrial Measures: Left atrial volume index (biplane area-length method). The above echocardiographic measures will be assessed by an independent core laboratory
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Time frame: 30 days post-procedure
Clinical Measure
6-minute walk test compared to baseline
Time frame: 30 day post-procedure
Clinical Measure
Quality of Life (KCCQ Questionnaire) compared to baseline
Time frame: 30 day post-procedure