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

NCT05854238 | Terminated

• 1 other identifier: TIRA-VoM
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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,

Conditions

Persistent Atrial Fibrillation

Keywords

Marshall vein ablation; radiofrequency catheter ablation; vein of Marshall ablation; VoM; TauPnu

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Efficacy of procedures(1)

  1 month post-procedure

• Efficacy of procedures(2)

  1 month post-procedure

• Adverse event(safety of procedures)(1)

  1 month post-procedure

• Adverse event(safety of procedures)(2)

  1 month post-procedure

Study Arms (1)

TIRA-VoM

EXPERIMENTAL

treated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)

Device: TIRA-VoM

Interventions

TIRA-VoM DEVICE

treat persistent atrial fibrillation * The ablation temperature range is 50-60℃ * About 2 minutes per ablation

Also known as: VA510, VA515, VA410, VA415, VoM

TIRA-VoM

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following criteria will be included.
• 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, intracardiac 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.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded.
• Patients whose computed tomography (CT) or antecedent venography performed at the screening visit demonstrates no identifiable Marshall's vein.
• Patients who have undergone catheter ablation for atrial fibrillation within 6 months prior to the screening visit, or who have undergone a surgical Maze procedure at any time.
• 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.

Sponsors & Collaborators

• Tau-MEDICAL Co., Ltd.: lead

Study Sites (2)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Min-Soo Cho, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: multicenter, open, single design, researcher-led, exploratory study

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 11, 2023
• Study Start: August 3, 2023
• Primary Completion: April 4, 2024
• Study Completion: April 7, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)