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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2023-01-25

Brief Summary

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

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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

Conditions

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Functional Tricuspid Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Pivot Balloon

mornitoring with transcatheter Tricuspid Regurgitation reduction system

Group Type EXPERIMENTAL

Pivot Balloon Catheter

Intervention Type DEVICE

mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

Interventions

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Pivot Balloon Catheter

mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No