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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tau-MEDICAL Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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