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Compares treatment options for Arrhythmias, Cardiac
Official title To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
ClinicalTrials.gov ID: NCT06358391
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 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
You likely can't join if
- [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...
- Thrombus in the left atrium
- Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)
- Known or suspected left atrial myxoma.
- Unstable angina.
See the full eligibility criteria
Who can 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
- 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...
- "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...
- "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...
- "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...
- "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...
- 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
What rules you out
- [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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bucheon-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bucheon-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.