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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Drug: Amiodarone Injection; Drug: Sodium Chloride Injection 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT06742866

ITAD-PAF

Details and patient eligibility

About

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.

Enrollment: 418 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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418 participants in 2 patient groups, including a placebo group

Experimental group (Intravenous + Oral Amiodarone)

Experimental group

Description:

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.

Treatment:

Drug: Amiodarone Injection

Control group (Oral Amiodarone only)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sodium Chloride Injection 0.9%