An interventional study of Pivot Bridge in Tricuspid Regurgitation Functional, sponsored by Tau-MEDICAL Co., Ltd.. Recruiting at 4 sites in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Tau-MEDICAL Co., Ltd. · Not applicable, Interventional, and Treatment
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Among 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of — 6 open to participants now, 7 under way, 1 of them phase 3. Tricuspid Valve Insufficiency · Korea, Republic of.
Among the 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of, this one is one of 2 that started in 2025, is one of 6 with no phase, and was the 12th registered.
227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.
Browse Tricuspid Valve Insufficiency studies →6 of the 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Samsung Medical Center · Sites in Korea, Republic of
Samsung Medical Center · Sites in Korea, Republic of
Ages 19+
Yonsei University · Sites in Korea, Republic of
Ages 19+
Daejeon St. Mary's hospital · Sites in Korea, Republic of
Ages 19+
Konkuk University Medical Center · Sites in Korea, Republic of
Ages 19–65
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 82 Tricuspid Valve Insufficiency studies recruiting now, 68 (83%) set no upper age limit and none (0%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 60 across 129 interventional studies indexed under Tricuspid Valve Insufficiency.
Median enrollment 70 across the 9 interventional studies, 566 across the 6 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 15 have an industry lead sponsor. The 7 most frequent:
Tau-MEDICAL Co., Ltd. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Tau-MEDICAL Co., Ltd. has 4 studies filed under Tricuspid Valve Insufficiency — fewer than ten, so there is no comparison to draw.
2 of the studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06027307Phase 3Asan Medical CenterEnavogliflozin Outcome Trial in Functional Tricuspid Regurgitation | 2027-06 |
| NCT07607093Samsung Medical CenterEfficacy of Early Rhythm Control in AF With TR Patients | 2027-02-28 |
Add all 2 to your calendar (.ics) → With an account.
Among the 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this clinical trial is as follows.
To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who have received medical therapy (diuretics/pharmacological treatment) for at least one month.
To evaluate clinical outcomes related to improvement of tricuspid regurgitation symptoms following implantation of the "Pivot Bridge" device, including procedure success and clinical success.
This study is designed as a self-controlled case series without a separate control group. The participant's non-exposure period to the investigational medical device, consisting of prior medical therapy (Medical Treatment, MT), is defined as the control period. The study compares (1) a period of fixed-dose medical therapy maintained for up to one week prior to application of the investigational medical device, and (2) a period during which the investigational medical device is temporarily implanted (within 1 week) in conjunction with medical therapy (Pivot Bridge, PB).
To quantitatively evaluate the efficacy of the investigational medical device in inducing improvement of tricuspid regurgitation, the following are assessed:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects who meet all of the following criteria will be enrolled
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged 18 years or older with massive or greater functional tricuspid regurgitation who have received medical therapy (diuretics and/or pharmacological treatment) for at least 1 month
Device: Pivot Bridge
The investigational "Pivot Bridge" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Bridge device is designed to sit in the space where the valve isn't closing, helping the flaps of the valve to close tightly and reducing the amount of blood leaking back through the valve.
Procedure Success Based on Improvement in Tricuspid Regurgitation Severity
Proportion of subjects achieving at least a 1-grade improvement in tricuspid regurgitation (TR grade) according to Tricuspid Valve Academic Research Consortium definitions
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)
Clinical Success Based on Clinical Improvement
The number of participants who experienced at least 1 drop in their TR grade from Baseline
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)
Clinical Success Based on Clinical Improvement(1)
Changes in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score (a measure of symptoms, physical limitation, social limitations and quality of life domains) from baseline. Participants will be asked to tick a box on a scale indicating how each domain affects their life (e.g. scales range from extremely limited to not at all limited, from every morning/night to never over the past 2 weeks, from completely dissatisfied to completely satisfied). The responses will be used to calculate an average score on a scale of 0 to 100. A higher score equates to better outcomes (i.e. fewer symptoms, better physical and social function, improved quality of life).
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)
Clinical Success Based on Clinical Improvement(2)
Changes in eGFR (estimated glomerular filtration rate) from baseline
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)
Clinical Success Based on Clinical Improvement(3)
Number of participants with at least 1 level of improvement in pitting edema from baseline
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)
Clinical Success Based on Clinical Improvement(4)
Number of participants with improvement in New York Heart Association (NYHA) functional class (system to classify the severity of heart failure symptoms) from baseline
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)
Clinical Success Based on Clinical Improvement(5)
Changes in echocardiogram (measurements and assessments of the heart's structure and function) as assessed by the central "Core Lab" reader
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (MT Day 4-7), Visit 3 (PB Day 4-7)
Clinical Success Based on Anatomical Improvement
Anatomical improvement : right ventricular volume, tricuspid valve annulus area, and other CT core lab analysis parameters
Time frame: Visit1 (Screening), Visit 3 (PB Day 4-7)
Clinical Success Within 3 Days After Device Removal
Changes in echocardiogram (measurements and assessments of the heart's structure and function) as assessed by the central "Core Lab" reader
Time frame: Visit 2 (Baseline, MT Day 0), Visit 3 (Post-removal)
Clinical Success at 1 Month After Device Removal
Changes in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score (a measure of symptoms, physical limitation, social limitations and quality of life domains) from baseline. Participants will be asked to tick a box on a scale indicating how each domain affects their life (e.g. scales range from extremely limited to not at all limited, from every morning/night to never over the past 2 weeks, from completely dissatisfied to completely satisfied). The responses will be used to calculate an average score on a scale of 0 to 100. A higher score equates to better outcomes (i.e. fewer symptoms, better physical and social function, improved quality of life).
Time frame: Visit 2 (Baseline, MT Day 0), Visit 4 (End of Study Visit, PB+ 1 Month)
Clinical Success at 1 Month After Device Removal(1)
Changes in eGFR (estimated glomerular filtration rate) from baseline
Time frame: Visit 2 (Baseline, MT Day 0), Visit 4 (End of Study Visit, PB+ 1 Month)
Clinical Success at 1 Month After Device Removal(2)
Number of participants with at least 1 level of improvement in pitting edema from baseline
Time frame: Visit 2 (Baseline, MT Day 0), Visit 4 (End of Study Visit, PB+ 1 Month)
Clinical Success at 1 Month After Device Removal(3)
Number of participants with improvement in New York Heart Association (NYHA) functional class (system to classify the severity of heart failure symptoms) from baseline
Time frame: Visit 2 (Baseline, MT Day 0), Visit 4 (End of Study Visit, PB+ 1 Month)
Clinical Success at 1 Month After Device Removal(4)
Changes in echocardiogram (measurements and assessments of the heart's structure and function) as assessed by the central "Core Lab" reader
Time frame: Visit 2 (Baseline, MT Day 0), Visit 4 (End of Study Visit, PB+ 1 Month)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jul 2026, 8 months after the start.
Of 55 industry-sponsored interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 70. This study's planned 8 months is below that.
Counting every sponsor, half of 86 studies reached it within 38 months; a quarter within 23 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Tricuspid Valve Insufficiency →
Tau-MEDICAL Co., Ltd.