An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia

Prior treatment

• Any prior cavo-tricuspid isthmus ablation;
• Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
• Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;
• Previously received tricuspid metal valve replacement;
• Enrollment in another clinical trial evaluating other devices or drugs during the same period;

Other illness

• Unstable angina;
• Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
• At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
• Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;
• Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;
• Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;
• Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;
• Acute systemic infection;
• Life expectancy less than 12 months (e.g. advanced malignancy);
• Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.

Lab values

• Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;

Other

• Implantable devices such as ICDs, CRTS and pacemakers in the body;
• Thromboembolic events (including transient ischemic attacks) within the past 6 months;
• Women who are pregnant or breastfeeding or who cannot use contraception during the study period;

• Subjects aged at least 18;
• Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
• Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.