A Phase 1/2 interventional study of Mitral Loop Cerclage Annuloplasty in Atrial Functional Mitral Regurgitation and Heart Failure, sponsored by Tau-MEDICAL Co., Ltd.. Completed at 7 sites in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Tau-MEDICAL Co., Ltd. · Phase 1/2, Interventional, and Treatment
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Among 147 studies in Heart Failure with a site in Korea, Republic of — 48 open to participants now, 53 under way, 12 of them phase 3. Heart Failure · Korea, Republic of.
Among the 147 studies in Heart Failure with a site in Korea, Republic of, this one is the 107th largest by enrollment of the 108 interventional ones that give a count, is one of 8 that started in 2018, is the only one in phase 1/2, and was the 48th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →48 of the 147 studies in Heart Failure with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Inha University Hospital · Sites in Korea, Republic of
Ages 19+
Oslo University Hospital · Sites in Korea, Republic of, United States, Belgium and 7 more countries
Ages 18+
AstraZeneca · Sites in Korea, Republic of, United States, Argentina and 29 more countries
Ages 18+
Kyungsub Song · Sites in Korea, Republic of
Ages 19+
Samsung Medical Center · 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 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 20 Years to 85 Years · 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.
147 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 16 · Phase 3 40 · Phase 4 15
First in 1983; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 264 across the 108 interventional studies, 815 across the 39 observational. Of the 73 that completed or were terminated, 38 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
83 of 147 have an industry lead sponsor. The 10 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 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
12 of the studies in Heart Failure with a site in Korea, Republic of that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
| NCT07111585Gachon University Gil Medical CenterPersonalized Health Coaching for Patients With HF | 2026-12 |
| NCT06122779Bristol-Myers SquibbStudy to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) | 2026-12-14 |
| NCT07379840BayerA Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South Korea | 2026-12-31 |
Add all 12 to your calendar (.ics) → With an account.
Among the 147 studies in Heart Failure 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.
To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device, in treating functional mitral regurgitation (FMR) associated with heart failure and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.
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.
(For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has for each drug)
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
Device: Mitral Loop Cerclage Annuloplasty
Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty
Also known as: (MLC-B-45-75-R and other 11 models)
Change of mitral regurgitation severity(1)
changing regurgitant volume (RV,mL) compared with baseline
Time frame: 1 month
Change of mitral regurgitation severity(2)
changing effective regurgitant orifice (ERO,cm\^2) compared with baseline
Time frame: 1 month
Change in mitral annulus geometry
septal lateral dimension(mm)
Time frame: 1 month
Rate of adverse events as a measure of safety
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \*death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Time frame: 1 month
Change of mitral regurgitation severity(1)
changing regurgitant volume (RV,mL) compared with baseline
Time frame: 6 months
Change of mitral regurgitation severity(2)
changing effective regurgitant orifice (ERO,cm\^2) compared with baseline
Time frame: 6 months
Change in mitral annulus geometry
septal lateral dimension(mm)
Time frame: 6 months
Change in left ventricle volumes
Changing of End-diastolic phase LV volumes(mL)
Time frame: 6 months
Electrical remodeling
change in electrocardiography (conversion of atrial fibrillation to normal sinus rhythm)
Time frame: 6 months
Change in subjects' symptoms referred to NYHA Classification System
NYHA (New York Heart Association)
Time frame: 6 months
Technical success rate of the implantation
Technical feasibility by the implantation success rate (%)
Time frame: 6 months
Rate of adverse events as a measure of safety
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \*death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Time frame: 6 months
Ran from Apr 2018 to primary completion in Nov 2018, 7 months.
Of 43 phase 1/2 interventional studies under Heart Failure, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 48. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Tau-MEDICAL Co., Ltd.