Amiodarone by vein plus pills versus pills alone after ablation for persistent atrial fibrillation
Compares amiodarone by vein and mouth with mouth alone after ablation.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with persistent atrial fibrillation who are having their first catheter ablation and who did not respond to, or could not tolerate, at least one antiarrhythmic drug.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Persistent atrial fibrillation (any previous episode lasting 7 days or more), with symptoms
- Earlier treatment
- Must have failed or not tolerated at least one class I or III antiarrhythmic drug. Must be having a catheter ablation for the first time.
Main reasons for not taking part
- Unwilling or unsuitable to restart or continue antiarrhythmic drug treatment
- Life expectancy under 12 months
- Severe liver or kidney problems
- Allergy to amiodarone or a reason amiodarone cannot be used (for example low blood pressure, slow heart rate, AV block, sick sinus syndrome)
- Thyroid disease, pregnancy or breastfeeding
Read by machine on 9 November 2026.
Where in China
- Shanghai Chest HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Chest Hospital
- Trial code
- NCT06742866
- Record updated
- 19 December 2024
- Original description
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.Read full original descriptionShow less
The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
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.
Inclusion: 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: Those unwilling or unsuitable to restart or continue antiarrhythmic drug therapy; Allergy to amiodarone components; 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; Life expectancy < 12 months; Severe liver or kidney dysfunction; Pregnant or breastfeeding women.