To evaluate 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
National Institues of Health
Bethesda, Maryland, United States
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Time frame: 1 month
Change in mitral annulus geometry (septal lateral dimension)
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 by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Time frame: 6 months
Change in mitral annulus geometry (septal lateral dimension)
Time frame: 6 months
Change in mitral valve hemodynamics
Time frame: 6 months
Change in left ventricle volumes
Time frame: 6 months
Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System
Time frame: 6 months
Technical success rate of the implantation and technical feasibility
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months