Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
The study for evaluation of safety and efficacy of Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilot study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
7
mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea
Hallym University Medical Center
Anyang, Dongan-gu, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
change of tricuspid regurgitation grade (1)
check the success of surgery /measure the size of the TR area
Time frame: immediately after the procedure
change of tricuspid regurgitation grade (2)
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
Time frame: immediately after the procedure
change of tricuspid regurgitation valve hemodynamics
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
Time frame: within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (1)
examine tricuspid regurgitation intolerance
Time frame: within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (2)
evaluate the technical success rate of the implantation and the technical feasibility of 'Pivot Balloon'
Time frame: within 24 h of insertion
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Chungnam National University Hospital (CNU Hospital)
Daejeon, Jung-gu, South Korea
Yeungnam University Hospital
Daegu, Nam-gu, South Korea
Ulsan Hospital
Ulsan, Nam-gu, South Korea
Chungnam National University Sejong Hospital
Sejong, Sejong-si, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Bucheon Sejong Hospital
Bucheon-si, South Korea
Samsung Medical Center
Seoul, South Korea