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Arrhythmias, CardiacNCT06358391

To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.

A study testing TS-RF Transseptal Needle and BRK Transseptal Needle in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Starmed at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TS-RF Transseptal Needle and BRK Transseptal Needle
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSouth Korea
Study dates
21 Aug 2024to 13 Oct 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age
  • Diagnosed with one of the following cardiac disorders as shown in the medical record:
  • [Symptomatic arrhythmia]
  • "Atrial fibrillation" diagnostics (including paroxysmal, persistent, long-standing persistent and permanent atrial fibrillation)
  • Diagnostic criteria: atrial fibrillation lasting ≥ 30 seconds as a result of standard 12-lead electrocardiogram (ECG) or single-lead ECG
  • ECG feature: irregular R-R interval, lack of visible P waves, irregular atrial activation
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  • Symptoms: fatigue, palpitation, dyspnea, chest discomfort, sleep disorders, mental stress
  • Type:
  • Paroxysmal atrial fibrillation (stopping within 48 hours without any treatment; restoring the sinus rhythm with cardioversion within 7 days)
  • Persistent atrial fibrillation (persisting for ≥ 7 days; including sinus rhythm restoration with direct-current cardioversion (DCC) or pharmacological cardioversion after the persistence)
  • Long-standing persistent atrial fibrillation (persisting for ≥ 1 year; including cases requiring cardioversion)
  • Permanent atrial fibrillation (The patient and healthcare provider accept atrial fibrillation and do not consider cardioversion; if cardioversion is considered, the atrial fibrillation is reclassified as long-standing persistent atrial fibrillation)
  • "Paroxysmal Supraventricular Tachycardia" diagnostics
  • = Clinical feature: The heart beats regularly 150 to 200 times per minute; the start and end of paroxysmal supraventricular tachycardia are clearly recognizable; these occur unexpectedly and stop abruptly.
  • "Ectopic Atrial Rhythm Tachycardia" diagnostics
  • = Clinical feature: Heart rhythm of less than 250 beats per minute; morphologic difference from P waves in the sinus rhythm; P waves that precede QRS waves are identifiable.
  • "Ventricular Tachycardia" diagnostics = Clinical feature: Wide QRS waves appear in succession with a rapid ventricular rate of ≥ 100 beats per minute; the patients is diagnosed with persistent ventricular tachycardia if tachycardia persists for ≥ 30 seconds but with non-persistent ventricular tachycardia if not applicable.
  • "Arrhythmia requiring left atrial access, including left atrial appendage occlusion, in the left atrium" diagnostics = Clinical feature: moderate or higher risk of stroke, risk of bleeding, or contraindication to anticoagulation therapy
  • [Symptomatic mitral stenosis]
  • -"Mitral Stenosis requiring percutaneous mitral valvuloplasty through left atrial access" diagnostics
  • Diagnostic criteria: confirmation of mitral stenosis with echocardiography and assessment of severity
  • Symptoms: dyspnea; shortness of breath even at rest or inability to sleep in a supine position if dyspnea worsens; may accompanied by coughing, sputum, and chest pain.
  • Understood this clinical study and voluntarily signed the informed consent form (ICF)1

Who cannot join

  • [For symptomatic arrhythmia and mitral stenosis] If any of the following applies, you cannot participate in this clinical trial.1,26,37,45,46
  • Patients with significant congenital heart defects, such as atrial septal defect or pulmonary vein (PV) abnormalities (excluding patent foramen ovale (PFO)).
  • Thrombus in the left atrium
  • Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)
  • Known or suspected left atrial myxoma.
  • Unstable angina.
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  • Pre-existing hemidiaphragmatic paralysis
  • Contraindication to anticoagulation or radiocontrast materials
  • liver disease (including active hepatitis) and kidney disease.
  • Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
  • Malignant tumors or hematological diseases or life expectancy of less than one (1) year.
  • Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
  • Unwilling or unable to comply fully with study procedures and follow-up
  • A pregnant woman, a woman planning on becoming pregnant, or a lactating woman.
  • Ineligible for study participation in the judgment of the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Bucheon Sejong Hospital

    Bucheon-si

Other trials in South Korea

About this study

Official title: A Prospective, Multi-center, Randomized, Single-blind, Non-inferiority Confirmatory Study Designed to Compare and Assess Efficacy and Safety Between "TS-RF System Consisting of a Electrosurgical System, General-purpose (TS-RF Generator) and a Electrosurgical System Electrode, Hand-controlled, General-purpose, Single-use (TS-RF Needle)" and "Needle, Puncture, Single-use (BRK Transseptal Needle)", Both of Which Are Used for the Transseptal Puncture Performed to Enable Left Atrial Access for the Treatment of Symptomatic Arrhythmia and Mitral Stenosis

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.

Read the detailed description

The efficacy and safety of radiofrequency (RF) needles in transseptal puncture have been well established through several comparative clinical studies. In foreign countries, RF needles have already been used for transseptal puncture for more than 20 years since the FDA approval of the first RF Needle. However, in Korea, despite the fact that it has been approximately 30 years since the initiation of radiofrequency catheter ablation (RFCA) for the treatment of arrhythmia, only the conventional mechanical needles have still been available after authorization for transseptal puncture that is the key for the treatment of cardiac disorders such as mitral stenosis as well as a part of RFCA for the treatment of arrhythmia.

Therefore, this study aims to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis, and then to demonstrate that the study device is non-inferior to the control device.

Being tested
TS-RF Transseptal Needle, BRK Transseptal Needle
Keywords
Transseptal puncture, Left atrial access, Transseptal catheterization, Radiofrequency
Medical subject headings
Arrhythmias, Cardiac, Atrial Fibrillation, Heart Diseases

What participants receive

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

  • TS-RF Transseptal NeedleDevice

    Apply radiofrequency energy to the electrode tip via the TS-RF Generator and puncture the atrial septum

  • BRK Transseptal NeedleDevice

    Cross and puncture the atrial septum with the BRK Transseptal Needle

Study groups in NCT06358391
Study groupRoleWhat they receive
Radiofrequency energy needleExperimentalRadiofrequency energy needle(TS-RF Needle) for transseptal access
Receives: Device: TS-RF Transseptal Needle
Mechanical needleActive comparatorMechanical needle(BRK Transseptal Needle) for transseptal access
Receives: Device: BRK Transseptal Needle

What is being measured

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

  1. First-pass TSP Success Rate (percent)

    Probability that the needle crosses from the superior vena cava to the fossa ovalis and its left atrial access is identified at a time by fluoroscopy, transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE).

    Measured: Day of procedure

Secondary outcomes (6)

  1. TSP Time (Second)

    Time from the point where the needle crosses from the superior vena cava to the fossa ovalis to the point where its left atrial access is identified by fluoroscopy, transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE).

    Measured: Day of procedure

  2. Fluoroscopy Time (Second) for TSP

    Time from the point where invasive vascular monitoring is initiated with fluoroscopy following the femoral venous puncture and then the needle inserted into the femoral vein is visible on the fluoroscope's fluorescent screen to the point where the needle tip's left atrial access after TSP is identified.

    Measured: Day of procedure

  3. Needle cross-over between the study and control groups

    Perform TSP by switching the needle from the BRK needle in the control group to the TS-RF needle in the study group, or from the TS-RF needle in the study group to the BRK needle in the control group. Collect the data based on the recorded videos and procedure record sheets. (Number of subjects who switched needles and percentage in each group)

    Measured: Day of procedure

  4. Intra-TSP procedural device-associated complications

    Collect and total the numbers of intra-TSP procedural device-associated complications for each group based on the procedure record sheets and then calculate and compare the group-specific incidence rates (percent).

    Measured: Day of procedure

  5. Changes in patient's quality of life

    Check the improvement in patient's quality of life by measuring the degree of discomfort due to symptomatic arrhythmia or mitral stenosis before the procedure (baseline) and at 2 weeks after the procedure.

    Calculate and compare group-specific mean changes in EQ-5D-5L and EQ-VAS before the procedure (baseline) and at the follow-up visit 2 weeks after the procedure.

    It consists of 5 multiple-choice questions asking about current health status and 1 question (visual analogue scale, VAS) that displays subjective health level (0 to 100 points) in the form of a thermometer.

    Measured: before the procedure (baseline) and at 2 weeks after the procedure.

  6. Complications

    Check the complications collected during the hospitalization period within 7 days immediately after the procedure and at the follow-up visit 2 weeks after the procedure, including the following two durations:.

    • From the end of TSP to the end of hospitalization within 7 days thereafter
    • From the discharge to the follow-up visit at 2 weeks after TSP

    Measured: for 2 weeks after the procedure

Timeline

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

  1. First posted10 Apr 2024
  2. Study start21 Aug 2024
  3. Primary completion13 Oct 2026
  4. Study completion13 Oct 2026

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06358391
Sponsor's protocol ID
TS-RF system
Status last verified
Oct 2026
First submitted
1 Apr 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A study testing TS-RF Transseptal Needle and BRK Transseptal Needle in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Starmed at 1 site 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 23 inclusion and 15 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: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

First-pass TSP Success Rate (percent) (time frame: Day of procedure). 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 NCT06358391.

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 Oct 2026.

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