Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR

Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

Inclusion Criteria:Adult males and females aged 20 years or aboveTarget of Thoracic Surgery for TR,[11] and patients above the severe level on the criteria presented in the Classification of TR Grade (Tabe 1) based on echocardiogram, among those with TR, for whom a surgical treatment has been decided*patients with left valve disease, left ventricular failure, and pulmonary arterial hypertension in addition to functional tricuspid regurgitation can be selectedAn individual who voluntarily agreed to the participation in the clinical trial and signed the written consentAn individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trialExclusion Criteria:Uncontrolled hyperthyroidismA recent formation of soft blood clot or embolic materialUncorrected coagulopathyProhibition of anticoagulant agentsPrevious insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemakerPresence of malignant tumor or benign tumor such as myxoma in the heartPresence of a symptom of active infectionChronic pulmonary diseaseCongenital tricuspid valve insufficiencySevere pulmonary arterial hypertension with a right ventricular systolic pressure (RVSP) of 70 mmHg or higherPregnant or lactating mother, or a female patient planning pregnancy during the period of clinical trial, or a female not using an approved contraceptive with the possibility of pregnancyParticipation in another clinical trial 30 days prior to the screeningIn addition, anyone showing a clinical finding deemed to be unsuitable for the clinical trial by the Principal Investigator or the Investigator