Functional Tricuspid Regurgitation
Conditions
Keywords
FTR, RV failure, TauPnu
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
Interventions
DEVICEPivot Balloon Catheter
mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
Sponsors
Tau-MEDICAL Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (1) | within 24 h of insertion | examine tricuspid regurgitation intolerance |
| 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' |
Countries
South Korea
Outcome results
None listed