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

NCT06742866 | Not Yet Recruiting DMC

• 1 other identifier: ITAD-PAF
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Recurrence of atrial fibrillation (AF) lasting more than 30 seconds.

  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.

  During the 3-month blanking period after atrial fibrillation (AF) surgery

• hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs)

  At least 12 months of follow-up

• Quality of life assessment using AFEQT

  At least 12 months of follow-up

• Serum drug concentrations of amiodarone and its metabolite desethylamiodarone.

  At 1 month and 3 months after surgery.

Study Arms (2)

Experimental group (Intravenous + Oral Amiodarone)

EXPERIMENTAL

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

Control group (Oral Amiodarone only)

PLACEBO COMPARATOR

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%

Interventions

Amiodarone Injection DRUG

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.

Experimental group (Intravenous + Oral Amiodarone)

Sodium Chloride Injection 0.9% DRUG

Sodium chloride injection as a placebo in an amount equivalent to amiodarone injection.

Control group (Oral Amiodarone only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Xuhui, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Shaohui Wu

CONTACT

15821960839; wushaohui18@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)