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

April 11, 2025 updated by: Seung-Whan Lee,MD,PhD, Tau-MEDICAL Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon-si, Korea, Republic of
        • Bucheon Sejong Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
    • Dalseo-gu
      • Daegu, Dalseo-gu, Korea, Republic of, 42601
        • Keimyung University Dongsan Hospital
    • Dongan-gu
      • Anyang, Dongan-gu, Korea, Republic of, 14068
        • Hallym University Medical Center
    • Gyeongsangnamdo
      • Yangsan, Gyeongsangnamdo, Korea, Republic of, 50602
        • Pusan National University Yangsan Hospital
    • Jung-gu
      • Daejeon, Jung-gu, Korea, Republic of, 35015
        • Chungnam National University Hospital (CNU Hospital)
    • Nam-gu
      • Daegu, Nam-gu, Korea, Republic of, 42415
        • Yeungnam University Hospital
      • Ulsan, Nam-gu, Korea, Republic of, 44686
        • Ulsan Hospital
    • Sejong-si
      • Sejong, Sejong-si, Korea, Republic of, 30099
        • Chungnam National University Sejong Hospital
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 05505
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of tricuspid regurgitation grade (1)
Time Frame: immediately after the procedure
check the success of surgery /measure the size of the TR area
immediately after the procedure
change of tricuspid regurgitation grade (2)
Time Frame: immediately after the procedure
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
Time Frame: within 24 h of insertion
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)
Time Frame: within 24 h of insertion
examine tricuspid regurgitation intolerance
within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (2)
Time Frame: within 24 h of insertion
evaluate the technical success rate of the implantation and the technical feasibility of 'Pivot Balloon'
within 24 h of insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tau-MEDICAL Co., Ltd.

Investigators

  • Principal Investigator: Seung-Whan Lee, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Actual)

January 25, 2023

Study Completion (Actual)

January 25, 2023

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pivot Balloon-FIM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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