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New needle could make heart procedures safer and faster

NCT ID NCT06358391

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device (TS-RF system) that uses radiofrequency energy to help doctors safely reach the left side of the heart during procedures for abnormal heart rhythms or mitral stenosis. About 70 adults will be randomly assigned to receive either the new device or a standard needle. The goal is to see if the new device works just as well and is as safe as the current method.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥ 18 years of age 2. 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 * 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. 3. Understood this clinical study and voluntarily signed the informed consent form (ICF)1 Exclusion Criteria: \[For symptomatic arrhythmia and mitral stenosis\] If any of the following applies, you cannot participate in this clinical trial.1,26,37,45,46 1. Patients with significant congenital heart defects, such as atrial septal defect or pulmonary vein (PV) abnormalities (excluding patent foramen ovale (PFO)). 2. Thrombus in the left atrium 3. Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery) 4. Known or suspected left atrial myxoma. 5. Unstable angina. 6. Pre-existing hemidiaphragmatic paralysis 7. Contraindication to anticoagulation or radiocontrast materials 8. liver disease (including active hepatitis) and kidney disease. 9. Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date 10. Malignant tumors or hematological diseases or life expectancy of less than one (1) year. 11. 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 12. Unwilling or unable to comply fully with study procedures and follow-up 13. A pregnant woman, a woman planning on becoming pregnant, or a lactating woman. 14. Ineligible for study participation in the judgment of the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bucheon Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.