To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
- Conditions
- Arrhythmias, CardiacAtrial FibrillationHeart Diseases
- Registration Number
- NCT06358391
- Lead Sponsor
- Starmed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. = 18 years of age<br><br> 2. Diagnosed with one of the following cardiac disorders as shown in the medical<br> record:<br><br> [Symptomatic arrhythmia]<br><br> - Atrial fibrillation diagnostics (including paroxysmal, persistent,<br> long-standing persistent and permanent atrial fibrillation)<br><br> - Diagnostic criteria: atrial fibrillation lasting = 30 seconds as a result<br> of standard 12-lead electrocardiogram (ECG) or single-lead ECG<br><br> - ECG feature: irregular R-R interval, lack of visible P waves, irregular<br> atrial activation<br><br> - Symptoms: fatigue, palpitation, dyspnea, chest discomfort, sleep<br> disorders, mental stress<br><br> - Type:<br><br> - Paroxysmal atrial fibrillation (stopping within 48 hours without any<br> treatment; restoring the sinus rhythm with cardioversion within 7<br> days)<br><br> - Persistent atrial fibrillation (persisting for = 7 days; including<br> sinus rhythm restoration with direct-current cardioversion (DCC) or<br> pharmacological cardioversion after the persistence)<br><br> - Long-standing persistent atrial fibrillation (persisting for = 1<br> year; including cases requiring cardioversion)<br><br> - Permanent atrial fibrillation (The patient and healthcare provider<br> accept atrial fibrillation and do not consider cardioversion; if<br> cardioversion is considered, the atrial fibrillation is reclassified<br> as long-standing persistent atrial fibrillation)<br><br> - Paroxysmal Supraventricular Tachycardia diagnostics<br><br> = Clinical feature: The heart beats regularly 150 to 200 times per minute; the<br> start and end of paroxysmal supraventricular tachycardia are clearly<br> recognizable; these occur unexpectedly and stop abruptly.<br><br> - Ectopic Atrial Rhythm Tachycardia diagnostics<br><br> = Clinical feature: Heart rhythm of less than 250 beats per minute; morphologic<br> difference from P waves in the sinus rhythm; P waves that precede QRS waves are<br> identifiable.<br><br> - Ventricular Tachycardia diagnostics = Clinical feature: Wide QRS waves appear<br> in succession with a rapid ventricular rate of = 100 beats per minute; the<br> patients is diagnosed with persistent ventricular tachycardia if tachycardia<br> persists for = 30 seconds but with non-persistent ventricular tachycardia if<br> not applicable.<br><br> - Arrhythmia requiring left atrial access, including left atrial appendage<br> occlusion, in the left atrium diagnostics = Clinical feature: moderate or<br> higher risk of stroke, risk of bleeding, or contraindication to anticoagulation<br> therapy<br><br> [Symptomatic mitral stenosis]<br><br> -Mitral Stenosis requiring percutaneous mitral valvuloplasty through left atrial<br> access diagnostics<br><br> - Diagnostic criteria: confirmation of mitral stenosis with echocardiography and<br> assessment of severity<br><br> - Symptoms: dyspnea; shortness of breath even at rest or inability to sleep in a<br> supine position if dyspnea worsens; may accompanied by coughing, sputum, and<br> chest pain.<br><br> 3. Understood this clinical study and voluntarily signed the informed consent form<br> (ICF)1<br><br>Exclusion Criteria:<br><br>[For symptomatic arrhythmia and mitral stenosis] If any of the following applies, you<br>cannot participate in this clinical trial.1,26,37,45,46<br><br> 1. Patients with significant congenital heart defects, such as atrial septal defect or<br> pulmonary vein (PV) abnormalities (excluding patent foramen ovale (PFO)).<br><br> 2. Thrombus in the left atrium<br><br> 3. Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)<br><br> 4. Known or suspected left atrial myxoma.<br><br> 5. Unstable angina.<br><br> 6. Pre-existing hemidiaphragmatic paralysis<br><br> 7. Contraindication to anticoagulation or radiocontrast materials<br><br> 8. liver disease (including active hepatitis) and kidney disease.<br><br> 9. Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding<br> the consent date<br><br> 10. Malignant tumors or hematological diseases or life expectancy of less than one (1)<br> year.<br><br> 11. Currently participating or anticipated to participate in any other clinical trial of<br> a drug, device or biologic that has the potential to interfere with the results of<br> this study<br><br> 12. Unwilling or unable to comply fully with study procedures and follow-up<br><br> 13. A pregnant woman, a woman planning on becoming pregnant, or a lactating woman.<br><br> 14. Ineligible for study participation in the judgment of the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First-pass TSP Success Rate (percent)
- Secondary Outcome Measures
Name Time Method TSP Time (Second);Fluoroscopy Time (Second) for TSP;Needle cross-over between the study and control groups;Intra-TSP procedural device-associated complications;Changes in patient's quality of life;Complications