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NCT Number: NCT06742866

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sodium Chloride Injection 0.9%

Drug

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.

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

    Time frame: At least 12 months of follow-up

    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.

  4. Quality of life assessment using AFEQT

    Time frame: At least 12 months of follow-up

    Assessment of quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life Questionnaire) during at least 12 months of follow-up.

  5. Serum drug concentrations of amiodarone and its metabolite desethylamiodarone.

    Time frame: At 1 month and 3 months after surgery.

    Serum drug concentrations of amiodarone and its metabolite desethylamiodarone at 1 month and 3 months after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Shaohui Wu

CONTACT

[email protected]

15821960839

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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