Clinical trial NCT06742866: Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
Official title: The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recurrence of atrial arrhythmia lasting more than 30 seconds.
timeFrame: At least 12 months of follow-up, beyond the initial 3 month blanking period
Secondary outcomes:
measure: Recurrence of atrial fibrillation (AF) lasting more than 30 seconds.
timeFrame: At least 12 months of follow-up, beyond the initial 3 month blanking period
measure: Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.
timeFrame: During the 3-month blanking period after atrial fibrillation (AF) surgery
measure: hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs)
timeFrame: At least 12 months of follow-up
measure: Quality of life assessment using AFEQT
timeFrame: At least 12 months of follow-up
measure: Serum drug concentrations of amiodarone and its metabolite desethylamiodarone.
timeFrame: At 1 month and 3 months after surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Xuhui
Study officials:
References: