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NOT YET RECRUITING
NCT06742866
NA

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

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

418

Start Date

2024-12-16

Completion Date

2026-07-01

Last Updated

2024-12-19

Healthy Volunteers

No

Interventions

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Xuhui, China