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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Drug: Amiodarone Injection; Drug: Sodium Chloride Injection 0.9%

• Study Type: Interventional
• Enrollment (Estimated): 418
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaohui Wu; Phone Number: 15821960839; Email: wushaohui18@163.com

Study Locations

• China
  • Xuhui
    • Shanghai, Xuhui, China
      • Shanghai Chest Hospital
      • Contact: Shaohui Wu; Phone Number: 15821960839; Email: wushaohui18@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (Intravenous + Oral Amiodarone); 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.	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.
Placebo Comparator: Control group (Oral Amiodarone only); 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.	Drug: Sodium Chloride Injection 0.9%; Sodium chloride injection as a placebo in an amount equivalent to amiodarone injection.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Arrhythmias, Cardiac; Recurrence; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Arrhythmia Agents; Sodium Channel Blockers; Membrane Transport Modulators; Cytochrome P-450 Enzyme Inhibitors; Vasodilator Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Potassium Channel Blockers; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Amiodarone
• Other Study ID Numbers: ITAD-PAF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No