Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amiodarone Injection, Sodium Chloride Injection 0.9%.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
Overview
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.
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.
Primary outcome measures
- Recurrence of atrial arrhythmia lasting more than 30 seconds. [Time frame: At least 12 months of follow-up, beyond the initial 3 month blanking period]
Secondary outcome measures (5)
- Recurrence of atrial fibrillation (AF) lasting more than 30 seconds. [Time frame: At least 12 months of follow-up, beyond the initial 3 month blanking period]
- Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery. [Time frame: During the 3-month blanking period after atrial fibrillation (AF) surgery]
- hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs) [Time frame: At least 12 months of follow-up]
- Quality of life assessment using AFEQT [Time frame: At least 12 months of follow-up]
- Serum drug concentrations of amiodarone and its metabolite desethylamiodarone. [Time frame: At 1 month and 3 months after surgery.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT06742866 · ITAD-PAF