The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF Ablation

Study Overview
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Brief Summary
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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,

Detailed Description
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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.

Official Title
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A Multicenter, Open, Single Design, Researcher-led, Phase 1 Exploratory Study to Evaluate the Safety and Efficacy of Vein of Marshall RF Ablation Using TIRA(VA510 and Other 3 Types) in Patients With Persistent Atrial Fibrillation

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: TIRA-VoM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women who are at least 20 years of age (80 years of age or older for geriatric patients). Patients requiring electrode ablation because of persistent arrhythmia despite use of antiarrhythmic drugs for more than 6 weeks Patients diagnosed with persistent atrial fibrillation after 2 consecutive electrocardiograms or 24-hour Holter test performed at least 1 week apart. Patients who have been on anticoagulants for more than 6 weeks or have taken equivalent safety measures. Patients with no evidence of intracardiac thrombus on transesophageal echocardiography or equivalent cardiac imaging (Cardiac CT) performed within 48 hours. Patients who have made a voluntary decision to participate in this study and have given written informed consent. Patients who are able to understand, follow instructions and participate for the full duration of the study. Exclusion Criteria: Patients whose computed tomography (CT) or antecedent venography demonstrate that Marshall's veins are less than 1 mm in diameter and less than 15 mm in length. Patient whose Marshall vein was confirmed to be less than 1 mm in diameter and less than 15 mm in length through computed tomography (CT) or total venogram. Patients who previously had atrial fibrillation ablation or Maze surgery Patients with a diagnosis of acute coronary syndrome within 3 months or who have undergone a stenting procedure or coronary artery bypass grafting in a coronary artery proximal to the anticipated procedure route at the time of the study. Patients with severe heart failure and those suffering from cardiogenic shock Those who are with less than 40% emissions Those with less than 40% of the ejection fraction Patients with hypertrophic cardiomyopathy Patients who have contraindications to contrast medias or anticoagulants Patients with evidence of intra-atrial thrombus on imaging studies performed within 1 month of the procedure Patients with evidence of blood clots in the atrium on imaging tests performed within 1 month of the procedure. Patients who have intracardiac malignant tumors and a life expectancy of 12 months or less Subjects with severe renal dysfunction (creatinine cleararnce < 30ml/min) Pregnant women, nursing mothers, and women who are planning to become pregnant or who may become pregnant during the study but are not using medically acceptable contraception Participation in other clinical trials within 30 days prior to screening Patients who participated in other clinical trials within 30 days prior to screening. In addition to the above, those who have clinical findings that the principal investigator or person in charge deems inappropriate for this study based on medical judgment. In addition to the above, those who have clinically signifcant findings that are considered inappropriate for this study as determined medically by the principal investigator or person in charge.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: multicenter, open, single design, researcher-led, exploratory study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIRA-VoM<br>treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices) | Device: TIRA-VoM<br>* treat persistent atrial fibrillation The ablation temperature range is 50-60℃ About 2 minutes per ablation<br>* Other names: VoM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vein of Marshall ablation, VoM, TauPnu, Marshall vein ablation, radiofrequency catheter ablation