NCT06742866

Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation

The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 418 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DRUG	Amiodarone Injection	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.
DRUG	Sodium Chloride Injection 0.9%	Sodium chloride injection as a placebo in an amount equivalent to amiodarone injection.

Timeline

• Start date: 2024-12-16
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: China