The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
The ARTO System directly reshapes the mitral annulus promoting leaflet coaptation and amelioration of regurgitation.
UC Davis Medical Center
Sacramento, California, United States
Safety: Major Adverse Event Rate to 30 Days post-procedure
Major Adverse Events (MAEs) will be categorized and defined in accordance with the relation to the procedure and device.
Time frame: 30 days post procedure
Efficacy: Mitral regurgitation grade by ASE criteria and change from baseline to 1 year
Mitral regurgitation grade by ASE criteria and change from baseline to 1 year evaluated by 2-D transthoracic echocardiogram
Time frame: Baseline to 1 year
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