An interventional study of Pivot Balloon Catheter in Functional Tricuspid Regurgitation, sponsored by Tau-MEDICAL Co., Ltd.. Completed at 10 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Tau-MEDICAL Co., Ltd. · Not applicable, Interventional, and Device feasibility
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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 2021, is one of 6 with no phase, and was the 6th 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+
Tau-MEDICAL Co., Ltd. · Sites in Korea, Republic of
Ages 18+
Yonsei University · Sites in Korea, Republic of
Ages 19+
Daejeon St. Mary's hospital · Sites in Korea, Republic of
Ages 19+
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: 20 Years and older · all sexes · no healthy volunteers.
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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 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 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.
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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 |
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Among the 15 studies in Tricuspid Valve Insufficiency with a site in Korea, Republic of, from their registry updates:
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Pivot Balloon to monitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
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
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.
Exclusion Criteria:
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.
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.
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.
mornitoring with transcatheter Tricuspid Regurgitation reduction system
Device: Pivot Balloon Catheter
mornitoring acute RV failure and reduction of Functional Tricuspid Regurgitation
change of tricuspid regurgitation grade (1)
check the success of surgery /measure the size of the TR area
Time frame: immediately after the procedure
change of tricuspid regurgitation grade (2)
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
Time frame: immediately after the procedure
change of tricuspid regurgitation valve hemodynamics
examine the changes in the severity of tricuspid valve insufficiency with Echocardiogram
Time frame: within 24 h of insertion
evaluate the efficacy based on the function of early diagnosis (1)
examine tricuspid regurgitation intolerance
Time frame: 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'
Time frame: within 24 h of insertion
Ran from Jul 2021 to primary completion in Jan 2023, 18 months.
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 18 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.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Tricuspid Valve Insufficiency →
Tau-MEDICAL Co., Ltd.