An interventional study of TIRA-VoM in Persistent Atrial Fibrillation, sponsored by Tau-MEDICAL Co., Ltd.. Terminated at 2 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Tau-MEDICAL Co., Ltd. · Not applicable, Interventional, and Device feasibility
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Among 207 studies in Atrial Fibrillation with a site in Korea, Republic of — 59 open to participants now, 67 under way, 2 of them phase 3. Atrial Fibrillation · Korea, Republic of.
Among the 207 studies in Atrial Fibrillation with a site in Korea, Republic of, this one is the 136th largest by enrollment of the 142 interventional ones that give a count, is one of 10 that started in 2023, is one of 89 with no phase, and was the 156th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →59 of the 207 studies in Atrial Fibrillation 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+
Chonnam National University Hospital · Sites in Korea, Republic of
Ages 19+
Samsung Medical Center · Sites in Korea, Republic of
Ages 19+
Yonsei University · 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 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 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.
207 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 3 · Phase 2 7 · Phase 3 22 · Phase 4 22
First in 2005; this study’s year is marked. 10 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 4 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Median enrollment 299 across the 142 interventional studies, 1,181 across the 65 observational. Of the 100 that completed or were terminated, 33 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
60 of 207 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 2 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
10 of the studies in Atrial Fibrillation 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 |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT07641582Seoul St. Mary's HospitalPrediction of Atrial Fibrillation Using Polygenic Risk Score | 2026-12-30 |
| NCT05507749Seoul National University HospitalCyroablation for Pulmonary Vein Isolation Alone in Patients With Early Persistent AF Assessed by Continuous Monitoring | 2026-12-31 |
| NCT05794386Seoul National University HospitalSCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation | 2026-12-31 |
| NCT07607093Samsung Medical CenterEfficacy of Early Rhythm Control in AF With TR Patients | 2027-02-28 |
Add all 10 to your calendar (.ics) → With an account.
Among the 207 studies in Atrial Fibrillation 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 goal of this clinical trial is to evaluate the initial safety and effectiveness of an investigational medical device.
Electrode catheter ablation of the Marshall vein is performed using TIRA, a clinical trial medical device for patients with persistent atrial fibrillation,
By analyzing the collected data, the initial safety and efficacy of the electrode catheter ablation effect of the clinical trial medical device is evaluated. After the clinical trial, the initial safety and efficacy of the electrode catheter ablation are evaluated by analyzing the changes in electrical signals before and after the procedure and by monitoring patients.
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.
Patients who meet all of the following criteria will be included.
Exclusion Criteria:
Patients 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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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 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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)
Device: TIRA-VoM
treat persistent atrial fibrillation * The ablation temperature range is 50-60℃ * About 2 minutes per ablation
Also known as: VA510, VA515, VA410, VA415, VoM
Changes of electrical signals around the Marshall vein(1)
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Time frame: Immediately after the procedure
Changes of electrical signals around the Marshall vein(2)
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Time frame: Immediately after the procedure
Changes of electrical signals around the Marshall vein
Observation of changes in unipolar electrogram between radiofrequency catheter and ground patch before and after resection: The size of the unipolar electrogram voltage before and after the procedure is compared, and if the reduction is more than 80%, it is evaluated as a successful ablation.
Time frame: Immediately after the procedure
Rate of adverse events as a measure of safety
Rate of composite endpoint of MACE death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke
Time frame: Immediately after the procedure
Efficacy of procedures(1)
The Standard 12 Lead ECG : Whether normal sinus rhythm is maintained after surgery
Time frame: 1 month post-procedure
Efficacy of procedures(2)
24-hour Holter monitoring : Recurrence rate of atrial tachycardia/atrial fibrillation more than 30 seconds after the procedure
Time frame: 1 month post-procedure
Adverse event(safety of procedures)(1)
All adverse event rate, including Serious Adverse Events (SAEs) and Serious Device Adverse Events (SADEs). : Myocardial infarction due to coronary artery damage, intracardiac conduction disorder, pericardial tamponade, cardiac surgery related to medical devices, stroke, death, etc.
Time frame: 1 month post-procedure
Adverse event(safety of procedures)(2)
CT : Whether there is contracture or narrowing of the pulmonary veins at the treatment site.
Time frame: 1 month post-procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Apr 2024, 8 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Tau-MEDICAL Co., Ltd.