Atrial fibrillation
Conditions
Interventions
Superior vena cava combined with circumferential pulmonary vein isolation group:Using a radiofrequency catheter for electrophysiological ablation, adopting the superior vena cava combined with circumf
PVI-only group:Using a radiofrequency catheter for electrophysiological ablation, adopting only the circumferential pulmonary vein isolation technique to ensure electrical isolation of all pulmonary v
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patient age between 18 and 75 years. 2.Documentation of atrial fibrillation on surface electrocardiogram or Holter monitor within 1 year prior to enrollment. 3.Clinical diagnosis of paroxysmal atrial fibrillation. 4.Symptomatic patients who have either failed or are intolerant to at least one antiarrhythmic drug; or patients who are willing to undergo ablation even without prior antiarrhythmic medication. 5.Full understanding of the treatment protocol, voluntary signing of the informed consent form, and willingness to undergo all required examinations, procedures, and follow-ups as outlined in the study protocol.
Exclusion criteria
Exclusion criteria: 1.Patients who have undergone left atrial surgery. 2.Presence of left atrial thrombus. 3.Patients with structural heart disease (e.g., hypertrophic cardiomyopathy, ischemic cardiomyopathy, dilated cardiomyopathy, valvular heart disease, congenital heart disease, etc.). 4.Women of childbearing potential who cannot take effective contraceptive measures during the 12-month follow-up period. 5.Left atrial anteroposterior diameter > 45 mm. 6.Left ventricular ejection fraction (LVEF) = 40%. 7.Patients with a history of atrial septal repair or atrial myxoma. 8.Patients with active implanted devices (e.g., pacemakers, implantable cardioverter defibrillators [ICD]). 9.Patients with New York Heart Association (NYHA) class III-IV heart failure. 10.Patients with documented cerebrovascular disease within the past 6 months (including cerebral hemorrhage, stroke, or transient ischemic attack). 11.Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention or coronary artery bypass graft surgery, artificial valve replacement or repair, atrial or ventricular septal surgery). 12.Patients with acute or severe systemic infections. 13.Patients with severe liver or kidney disease, malignant tumors, or end-stage diseases that, in the investigator’s opinion, may interfere with the treatment, assessment, or compliance in this trial. 14.Patients with a marked bleeding tendency, hypercoagulable states, or severe hematologic disorders. 15.Any other conditions that, in the investigator’s judgment, would make the patient unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sinus rhythm maintenance rate;Incidence of perioperative adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate ablation success rate (restoration of sinus rhythm);Process data evaluation (including intraoperative fluoroscopy time, total procedure time, high-frequency activation patterns, etc; | — |
Countries
China
Contacts
Public ContactWenqing Zhu
Zhongshan Hospital, Fudan University
Outcome results
None listed