evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
transcatheter for short-term treat Functional Tricuspid regurgitation
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea
Hallym University Medical Center
Anyang, Dongan-gu, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Assessment of Acute phase safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Time frame: immediately after the procedure
Efficacy endpoint-1: Changes of hemodynamics
Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(1)
Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(2)
Echocardiogram: Fractional area change in percentage
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(3)
Echocardiogram: LVEF in percentage
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(4)
Echocardiogram: Peak systolic annular velocity in cm/sec
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(5)
Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(6)
Echocardiogram: LVOT stroke volume in ml
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Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Chungnam National University Hospital (CNU Hospital)
Daejeon, Jung-gu, South Korea
Chungnam National University sejong Hospital
Daejeon, Jung-gu, South Korea
Ulsan Hospital
Ulsan, Nam-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Bucheon Sejong Hospital
Bucheon-si, South Korea
Samsung Medical Center
Seoul, South Korea
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(7)
Echocardiogram: TV annular diameter in mm
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(8)
Echocardiogram: RV diameter base in mm
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(9)
Echocardiogram: Inferior vena cava diameter and PW tracing - Assessment of the presence or absence of systolic flow reversal
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(10)
Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(11)
Cardiac CT : RV volume in ml
Time frame: within 1week of implant
Efficacy endpoint-2: Technical feasibility and TR grade changes
Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters
Time frame: within 1week of implant
Assessment of short-term safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Time frame: within 1week of implant