We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
390
Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
Shanghai, Shanghai Municipality, China
Freedom from AF recurrence between 91 and 365 days
AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence.
Time frame: 91 to 365 days
AF burden
Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.
Time frame: 12 months
Procedural time
Total procedural time from femoral vein puncture to decannulation (skin-to-skin time)
Time frame: Within procedure
Fluoroscopy time
Time of patients' exposure to the real-time X-ray imaging during the procedure.
Time frame: Within procedure
Ablation time
Radiofrequency delivery time during the procedure.
Time frame: Within procedure
Early onset complications
Complications within 30 days post-ablation, including death, myocardial infarction, diaphragmatic paralysis, stroke or transient ischemic attack, systemic embolism, pericardial effusion or tamponade requiring drainage, heart block, pericarditis, and vascular access complications requiring intervention.
Time frame: Within 30 days
Late onset complications
Complications detected any time during the follow-up, including severe pulmonary vein stenosis (\>70%), and atrioesophageal fistula.
Time frame: within 12 months
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