Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR
- Conditions
- Functional Tricuspid Regurgitation
- Interventions
- Device: Pivot Balloon Catheter
- Registration Number
- NCT05648838
- Lead Sponsor
- Tau-MEDICAL Co., Ltd.
- Brief Summary
Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- Adult males and females aged 20 years or above
- Target of Thoracic Surgery for TR and patients above the severe level on the criteria presented in the Classification of TR Grade based on echocardiogram, among those with TR, for whom a surgical treatment has been decided
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pivot Balloon Pivot Balloon Catheter mornitoring with transcatheter Tricuspid Regurgitation reduction system
- Primary Outcome Measures
Name Time Method change of tricuspid regurgitation grade (1) immediately after the procedure check the success of surgery /measure the size of the TR area
change of tricuspid regurgitation grade (2) immediately after the procedure examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
- Secondary Outcome Measures
Name Time Method change of tricuspid regurgitation valve hemodynamics within 24 h of insertion examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
evaluate the efficacy based on the function of early diagnosis (2) within 24 h of insertion evaluate the technical success rate of the implantation and the technical feasibility of 'Pivot Balloon'
evaluate the efficacy based on the function of early diagnosis (1) within 24 h of insertion examine tricuspid regurgitation intolerance
Trial Locations
- Locations (10)
Hallym University Medical Center
🇰🇷Anyang, Dongan-gu, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Dalseo-gu, Korea, Republic of
Chungnam National University Hospital (CNU Hospital)
🇰🇷Daejeon, Jung-gu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangnamdo, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Nam-gu, Korea, Republic of
Ulsan Hospital
🇰🇷Ulsan, Nam-gu, Korea, Republic of
Chungnam National University Sejong Hospital
🇰🇷Sejong, Sejong-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Bucheon Sejong Hospital
🇰🇷Bucheon-si, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of