To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device, in treating functional mitral regurgitation (FMR) associated with heart failure and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea
Sejong HOSPITAL
Bucheon-si, Gyeonggi-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Chungnam National University Hospital (CNU Hospital)
Daejeon, Jung-gu, South Korea
Change of mitral regurgitation severity(1)
changing regurgitant volume (RV,mL) compared with baseline
Time frame: 1 month
Change of mitral regurgitation severity(2)
changing effective regurgitant orifice (ERO,cm\^2) compared with baseline
Time frame: 1 month
Change in mitral annulus geometry
septal lateral dimension(mm)
Time frame: 1 month
Rate of adverse events as a measure of safety
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \*death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Time frame: 1 month
Change of mitral regurgitation severity(1)
changing regurgitant volume (RV,mL) compared with baseline
Time frame: 6 months
Change of mitral regurgitation severity(2)
changing effective regurgitant orifice (ERO,cm\^2) compared with baseline
Time frame: 6 months
Change in mitral annulus geometry
septal lateral dimension(mm)
Time frame: 6 months
Change in left ventricle volumes
Changing of End-diastolic phase LV volumes(mL)
Time frame: 6 months
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Yeungnam University Hospital
Daegu, Nam-gu, South Korea
Ulsan Hospital
Ulsan, Nam-gu, South Korea
ASAN Medical Center
Seoul, Songpa-gu, South Korea
Electrical remodeling
change in electrocardiography (conversion of atrial fibrillation to normal sinus rhythm)
Time frame: 6 months
Change in subjects' symptoms referred to NYHA Classification System
NYHA (New York Heart Association)
Time frame: 6 months
Technical success rate of the implantation
Technical feasibility by the implantation success rate (%)
Time frame: 6 months
Rate of adverse events as a measure of safety
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \*death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Time frame: 6 months