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

Korábbi kezelés

• Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)
• 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

Más betegség

• [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)).
• Unstable angina.
• liver disease (including active hepatitis) and kidney disease.
• Malignant tumors or hematological diseases or life expectancy of less than one (1) year.

Egyéb

• Thrombus in the left atrium
• Known or suspected left atrial myxoma.
• Pre-existing hemidiaphragmatic paralysis
• Contraindication to anticoagulation or radiocontrast materials
• Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
• 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.

• ≥ 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 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