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

Tau-MEDICAL Co., Ltd.

Status: Completed

Conditions: Functional Tricuspid Regurgitation

Treatments: Device: Pivot Balloon Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05648838

Pivot Balloon-FIM

Details and patient eligibility

About

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

Full 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

Enrollment: 7 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Pivot Balloon

Experimental group

Description:

mornitoring with transcatheter Tricuspid Regurgitation reduction system

Treatment:

Device: Pivot Balloon Catheter