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

Study Overview
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Brief Summary
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Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

Detailed Description
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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

Official Title
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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

Conditions
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Functional Tricuspid Regurgitation

Intervention / Treatment
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* Device: Pivot Balloon Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and females aged 20 years or above Target 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 selected An individual who voluntarily agreed to the participation in the clinical trial and signed the written consent An individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trial Exclusion Criteria: Uncontrolled hyperthyroidism A recent formation of soft blood clot or embolic material Uncorrected coagulopathy Prohibition of anticoagulant agents Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker Presence of malignant tumor or benign tumor such as myxoma in the heart Presence of a symptom of active infection Chronic pulmonary disease Congenital tricuspid valve insufficiency Severe pulmonary arterial hypertension with a right ventricular systolic pressure (RVSP) of 70 mmHg or higher Pregnant 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 pregnancy Participation in another clinical trial 30 days prior to the screening In addition, anyone showing a clinical finding deemed to be unsuitable for the clinical trial by the Principal Investigator or the Investigator

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pivot Balloon<br>mornitoring with transcatheter Tricuspid Regurgitation reduction system | Device: Pivot Balloon Catheter<br>* mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of tricuspid regurgitation grade (1) | check the success of surgery /measure the size of the TR area | immediately after the procedure | 
| change of tricuspid regurgitation grade (2) | examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram | immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of tricuspid regurgitation valve hemodynamics | examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram | within 24 h of insertion | 
| evaluate the efficacy based on the function of early diagnosis (1) | examine tricuspid regurgitation intolerance | 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' | within 24 h of insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FTR, RV failure, TauPnu