An interventional study of Pivot Bridge 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 2024-02-08.
Sponsored by Tau-MEDICAL Co., Ltd. · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 2023, is one of 6 with no phase, and was the 8th 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.
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 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 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.
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t 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.
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.
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.
transcatheter for short-term treat Functional Tricuspid regurgitation
Device: Pivot Bridge
transcatheter for short-term treat Functional Tricuspid regurgitation
Assessment of Acute phase safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Time frame: immediately after the procedure
Efficacy endpoint-1: Changes of hemodynamics
Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(1)
Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(2)
Echocardiogram: Fractional area change in percentage
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(3)
Echocardiogram: LVEF in percentage
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(4)
Echocardiogram: Peak systolic annular velocity in cm/sec
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(5)
Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(6)
Echocardiogram: LVOT stroke volume in ml
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(7)
Echocardiogram: TV annular diameter in mm
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(8)
Echocardiogram: RV diameter base in mm
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(9)
Echocardiogram: Inferior vena cava diameter and PW tracing - Assessment of the presence or absence of systolic flow reversal
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(10)
Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio
Time frame: within 1week of implant
Efficacy endpoint-1: Changes of hemodynamics(11)
Cardiac CT : RV volume in ml
Time frame: within 1week of implant
Efficacy endpoint-2: Technical feasibility and TR grade changes
Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters
Time frame: within 1week of implant
Assessment of short-term safety
Check all adverse reactions Including serious adverse events and serious adverse medical device reactions
Time frame: within 1week of implant
Plan to share: Undecided
Ran from Mar 2023 to primary completion in Oct 2023, 7 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 7 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 Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tricuspid Valve Insufficiency →
Tau-MEDICAL Co., Ltd.