This study aims to investigate the efficacy and safety of intravenous combined with oral amiodarone in preventing atrial fibrillation (AF) recurrence after catheter ablation in patients with persistent atrial fibrillation. Using a randomized controlled trial design, patients will be divided into two groups: intravenous + oral amiodarone and oral amiodarone alone. Through multiple follow-ups at 1, 3, 6, and 12 months post-procedure, the study will compare the two treatment regimens in terms of blood concentrations of amiodarone and its metabolites, efficacy (short-term recurrence \[SR\], long-term recurrence \[LR\], and patient quality of life), and safety (adverse drug reactions). Subgroup analyses will also be conducted to explore potential differences in drug treatment effects among populations with varying risk factors. This study aims to provide valuable clinical data for post-ablation management of atrial fibrillation, contributing to the development of optimized treatment strategies to enhance therapeutic outcomes and improve patient quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
418
Administer 300 mg of intravenous amiodarone as a loading dose once daily (QD) and 200 mg of oral amiodarone twice daily (BID) within 24 hours postoperatively, and continue for 3 consecutive days.
Sodium chloride injection as a placebo in an amount equivalent to amiodarone injection.
Shanghai Chest Hospital
Shanghai, Xuhui, China
Recurrence of atrial arrhythmia lasting more than 30 seconds.
After a single ablation procedure, with at least 12 months of follow-up, any atrial arrhythmia recorded for more than 30 seconds - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - occurring beyond the initial 3-month blanking period.
Time frame: At least 12 months of follow-up, beyond the initial 3 month blanking period
Recurrence of atrial fibrillation (AF) lasting more than 30 seconds.
After a single ablation procedure, with at least 12 months of follow-up, any atrial arrhythmia recorded for more than 30 seconds - including atrial fibrillation (AF) - occurring beyond the initial 3-month blanking period.
Time frame: At least 12 months of follow-up, beyond the initial 3 month blanking period
Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.
Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.
Time frame: During the 3-month blanking period after atrial fibrillation (AF) surgery
hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs)
During the follow-up period, hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs), including bleeding, liver dysfunction, renal dysfunction, skin sensitivity, gastrointestinal adverse reactions, bradyarrhythmia (\<55 bpm), ischemic stroke, and hyperthyroidism, etc.
Time frame: At least 12 months of follow-up
Quality of life assessment using AFEQT
Assessment of quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life Questionnaire) during at least 12 months of follow-up.
Time frame: At least 12 months of follow-up
Serum drug concentrations of amiodarone and its metabolite desethylamiodarone.
Serum drug concentrations of amiodarone and its metabolite desethylamiodarone at 1 month and 3 months after surgery.
Time frame: At 1 month and 3 months after surgery.
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