New needle could make heart procedures safer and faster
NCT ID NCT06358391
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Arrhythmias, cardiac are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGBucheon-si, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation
- Suture device may get heart patients walking sooner after leg vein procedures
- Two ways to catch a hidden heart rhythm after stroke
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?