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The study was terminated without extension as the approved period expired before enrollment completion. Few eligible subjects were found, and investigators agreed not to extend the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIRA-VoM | Experimental | treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIRA-VoM | Device | treat persistent atrial fibrillation
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of procedures(1) | The Standard 12 Lead ECG : Whether normal sinus rhythm is maintained after surgery | 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 |
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Inclusion Criteria:
Patients who meet all of the following criteria will be included.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Min-Soo Cho, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 626-770 | South Korea | ||
| Asan Medical Center |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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multicenter, open, single design, researcher-led, exploratory study
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| 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. | 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. | 1 month post-procedure |
| Seoul |
| Songpa-gu |
| 05505 |
| South Korea |
| D013568 |
| Pathological Conditions, Signs and Symptoms |