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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)
• Interventions: Drug: Amiodarone Injection; Drug: Sodium Chloride Injection 0.9%

• Registration Number: NCT06742866
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-16
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

• Participants aged ≥18 years;
• First-time catheter ablation for persistent atrial fibrillation (defined as any - previous episode lasting ≥7 days);
• Symptomatic atrial fibrillation patients who have failed or are intolerant to at least one class I or III antiarrhythmic drug;
• Participants who are able to understand the purpose of the study, voluntarily agree to participate, and provide written informed consent.

Exclusion Criteria

• Those unwilling or unsuitable to restart or continue antiarrhythmic drug therapy;
• Life expectancy < 12 months;
• Severe liver or kidney dysfunction;
• Allergy to amiodarone components;
• Pregnant or breastfeeding women;
• Contraindications to amiodarone (e.g., blood pressure < 90/60 mmHg; bradycardia < 55 bpm, second- or third-degree AV block, or sick sinus syndrome);
• Thyroid disorders, such as hyperthyroidism or hypothyroidism.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (Intravenous + Oral Amiodarone)	Amiodarone Injection	Within 24 hours post-operation, patients will receive an intravenous amiodarone loading dose of 300 mg QD along with oral amiodarone 200 mg BID. This regimen will be continued for 3 days, after which intravenous amiodarone will be discontinued, and oral amiodarone 200 mg BID will be continued for 3 months.
Control group (Oral Amiodarone only)	Sodium Chloride Injection 0.9%	Postoperatively, instead of administering intravenous amiodarone, sodium chloride injection was used as a placebo, and oral amiodarone 200 mg BID was directly given for 3 months.

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial arrhythmia lasting more than 30 seconds.	At least 12 months of follow-up, beyond the initial 3 month blanking period	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.

Secondary Outcome Measures

Name	Time	Method
hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs)	At least 12 months of follow-up	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.
Quality of life assessment using AFEQT	At least 12 months of follow-up	Assessment of quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life Questionnaire) during at least 12 months of follow-up.
Serum drug concentrations of amiodarone and its metabolite desethylamiodarone.	At 1 month and 3 months after surgery.	Serum drug concentrations of amiodarone and its metabolite desethylamiodarone at 1 month and 3 months after surgery.
Recurrence of atrial fibrillation (AF) lasting more than 30 seconds.	At least 12 months of follow-up, beyond the initial 3 month blanking period	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.
Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.	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.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Xuhui, China