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

Sponsor

Tau Pnu Medical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05854238

Collaborator

(none)

Enrollment

Locations

Arm

22.2

Anticipated Duration (Months)

3.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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,

Condition or Disease	Intervention/Treatment	Phase
Persistent Atrial Fibrillation	Device: TIRA-VoM	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

multicenter, open, single design, researcher-led, exploratory studymulticenter, open, single design, researcher-led, exploratory study

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Anticipated Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Nov 7, 2024

Anticipated Study Completion Date :

Apr 7, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TIRA-VoM 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 Other Names: VA510, VA515, VA410, VA415 VoM

Arm

Intervention/Treatment

Experimental: TIRA-VoM

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

Other Names:

VA510, VA515, VA410, VA415

VoM

Outcome Measures

Primary Outcome Measures

Changes of electrical signals around the Marshall vein(1) [Immediately after the procedure]
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Changes of electrical signals around the Marshall vein(2) [Immediately after the procedure]
Pacing progress through unipolar electrogram between radiofrequency catheter and ground patch: Failure to conduction is evaluated as successful ablation.
Changes of electrical signals around the Marshall vein [Immediately after the procedure]
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.
Rate of adverse events as a measure of safety [Immediately after the procedure]
Rate of composite endpoint of MACE death, myocardial infarction, cardiac tamponade, device related acrdiac surgery, stroke

Secondary Outcome Measures

Efficacy of procedures(1) [1 month post-procedure]
The Standard 12 Lead ECG : Whether normal sinus rhythm is maintained after surgery
Efficacy of procedures(2) [1 month post-procedure]
24-hour Holter monitoring : Recurrence rate of atrial tachycardia/atrial fibrillation more than 30 seconds after the procedure
Adverse event(safety of procedures)(1) [1 month post-procedure]
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.
Adverse event(safety of procedures)(2) [1 month post-procedure]
CT : Whether there is contracture or narrowing of the pulmonary veins at the treatment site.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.