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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
4
treat persistent atrial fibrillation * The ablation temperature range is 50-60℃ * About 2 minutes per ablation
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
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
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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