Functional Tricuspid RegurgitationNCT05648838
Evaluation of Safety and Efficacy of Pivot Balloon to Monitoring Acute RV Failure and Reduction of FTR
A study testing Pivot Balloon Catheter in people with Functional Tricuspid Regurgitation, run by Tau-MEDICAL Co., Ltd. at 10 sites in South Korea.
Trial summary
Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Functional Tricuspid Regurgitation
- What is being tested?
- Pivot Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 19 Jul 2021to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Hallym University Medical Center
Anyang, Dongan-gu, 14068
Bucheon Sejong Hospital
Bucheon-si
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, 42601
Yeungnam University Hospital
Daegu, Nam-gu, 42415
Chungnam National University Hospital (CNU Hospital)
Daejeon, Jung-gu, 35015
Chungnam National University Sejong Hospital
Sejong, Sejong-si, 30099
Asan Medical Center
Seoul, Songpa-gu, 05505
Samsung Medical Center
Seoul
Ulsan Hospital
Ulsan, Nam-gu, 44686
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50602
About this study
Official title: 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
Read the 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
- Conditions
- Functional Tricuspid Regurgitation
- Being tested
- Pivot Balloon Catheter
- Keywords
- FTR, RV failure, TauPnu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivot Balloon CatheterDevice
mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Pivot Balloon | Experimental | mornitoring with transcatheter Tricuspid Regurgitation reduction system Receives: Device: Pivot Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of tricuspid regurgitation grade (1)
check the success of surgery /measure the size of the TR area
Measured: immediately after the procedure
change of tricuspid regurgitation grade (2)
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
Measured: immediately after the procedure
Secondary outcomes (3)
change of tricuspid regurgitation valve hemodynamics
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
Measured: within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (1)
examine tricuspid regurgitation intolerance
Measured: within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (2)
evaluate the technical success rate of the implantation and the technical feasibility of 'Pivot Balloon'
Measured: within 24 h of insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start19 Jul 2021
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tau-MEDICAL Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Seung-Whan Lee,MD,PhD, Asan Medical Center
- Investigators
- Seung-Whan Lee, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648838
- Sponsor's protocol ID
- Pivot Balloon-FIM
- Status last verified
- Apr 2025
- First submitted
- 5 Dec 2022
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Downie IP, Evans BT. Re: Holmes S, Hutchison I. Reconstruction of the orbital floor after its removal for malignancy. Br J Oral Maxillofac Surg 2001; 39: 158-159. Br J Oral Maxillofac Surg. 2001 Dec;39(6):485. doi: 10.1054/bjom.2001.0679. No abstract available.
PubMed 11735152Kim EK, Chon MK, Kim HS, Park YH, Lee SH, Choo KS, Je HG, Kim DH, Kim TO, Koh YS, Park JH, Lee JH, Choi YJ, Shin ES, Yoon HJ, Lee SW, Hahn JY. Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation: The First-in-Man Experiences. Korean Circ J. 2025 Jan;55(1):20-31. doi: 10.4070/kcj.2024.0147. Epub 2024 Oct 14.
PubMed 39601393
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05648838
- Acronym / sponsor ID
- Pivot Balloon-FIM
- Conditions
- Functional Tricuspid Regurgitation
- Keywords
- FTR, RV failure, TauPnu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tau-MEDICAL Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pivot Balloon | Experimental | Device: Pivot Balloon Cathetermornitoring with transcatheter Tricuspid Regurgitation reduction system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pivot Balloon Cathetermornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation | Device | Pivot Balloon |
Primary outcome
change of tricuspid regurgitation grade (1)
Time frame: immediately after the procedure
check the success of surgery /measure the size of the TR area
change of tricuspid regurgitation grade (2)
Time frame: immediately after the procedure
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
3 secondary outcomes
change of tricuspid regurgitation valve hemodynamics
Time frame: within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (1)
Time frame: within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (2)
Time frame: within 24 h of insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Results publication: PubMed 11735152Downie IP, Evans BT. Re: Holmes S, Hutchison I. Reconstruction of the orbital floor after its removal for malignancy. Br J Oral Maxillofac Surg 2001; 39: 158-159. Br J Oral Maxillofac Surg. 2001 Dec;39(6):485. doi: 10.1054/bjom.2001.0679. No abstract available.
- Derived from this study: PubMed 39601393Kim EK, Chon MK, Kim HS, Park YH, Lee SH, Choo KS, Je HG, Kim DH, Kim TO, Koh YS, Park JH, Lee JH, Choi YJ, Shin ES, Yoon HJ, Lee SW, Hahn JY. Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation: The First-in-Man Experiences. Korean Circ J. 2025 Jan;55(1):20-31. doi: 10.4070/kcj.2024.0147. Epub 2024 Oct 14.
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Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
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RecruitingObservational study
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Whan Lee, PhD principal investigator
Asan Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pivot Balloon Catheter in people with Functional Tricuspid Regurgitation, run by Tau-MEDICAL Co., Ltd. at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of tricuspid regurgitation grade (1) (time frame: immediately after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648838, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.