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Persistent Atrial FibrillationNCT05854238

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

A study testing TIRA-VoM in people with Persistent Atrial Fibrillation, run by Tau-MEDICAL Co., Ltd. at 2 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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, Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
TIRA-VoM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesSouth Korea
Study dates
3 Aug 2023to 7 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 626-770

Other trials in South Korea

About this study

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

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,

Read the 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.

Being tested
TIRA-VoM
Keywords
Marshall vein ablation, radiofrequency catheter ablation, vein of Marshall ablation, VoM, TauPnu
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIRA-VoMDevice

    Also called VA510, VA515, VA410, VA415, VoM

    treat persistent atrial fibrillation

    • The ablation temperature range is 50-60℃
    • About 2 minutes per ablation
Study groups in NCT05854238
Study groupRoleWhat they receive
TIRA-VoMExperimentaltreated with transcatheter RF ablation system (TIRA catheter with its supplemental devices)
Receives: Device: TIRA-VoM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediately after the procedure

  2. 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.

    Measured: Immediately after the procedure

  3. 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.

    Measured: Immediately after the procedure

  4. 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

    Measured: Immediately after the procedure

Secondary outcomes (4)

  1. Efficacy of procedures(1)

    The Standard 12 Lead ECG : Whether normal sinus rhythm is maintained after surgery

    Measured: 1 month post-procedure

  2. Efficacy of procedures(2)

    24-hour Holter monitoring : Recurrence rate of atrial tachycardia/atrial fibrillation more than 30 seconds after the procedure

    Measured: 1 month post-procedure

  3. 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.

    Measured: 1 month post-procedure

  4. Adverse event(safety of procedures)(2)

    CT : Whether there is contracture or narrowing of the pulmonary veins at the treatment site.

    Measured: 1 month post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start3 Aug 2023
  3. Primary completion4 Apr 2024
  4. Study completion7 Apr 2025

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
multicenter, open, single design, researcher-led, exploratory study
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854238
Sponsor's protocol ID
TIRA-VoM
Status last verified
Apr 2025
First submitted
21 Apr 2023
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TIRA-VoM in people with Persistent Atrial Fibrillation, run by Tau-MEDICAL Co., Ltd. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of electrical signals around the Marshall vein(1) (time frame: Immediately after the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05854238.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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