Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation

Korábbi kezelés

• Prior surgical or catheter ablation for any type of cardiac arrhythmia;
• Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
• Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure;
• History of prior cardiothoracic surgery;

Más betegség

• AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
• History of permanent pacemaker implantation;
• History of malignancy;
• Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
• History of allergy to contrast;

Laborértékek

• Serum creatinine > 2 times the upper limit of normal, or currently on dialysis;

Egyéb

• Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
• Sinus node dysfunction or other indications for permanent pacemaker implantation;
• Left atrial anteroposterior diameter ≥ 50 mm;
• Long-term use of a central venous catheter;
• Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period;
• Subjects or their legally authorized representatives who are unwilling to provide written informed consent;
• Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits;
• Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.

• Age ≥ 18 years;
• Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months;
• Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China;
• Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy;
• Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.