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

NCT ID: NCT06742866

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Amiodarone Injection

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Sodium Chloride Injection 0.9%

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Sodium Chloride Injection 0.9%

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, Xuhui, China

Site Status

Countries

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China

Central Contacts

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Shaohui Wu

Role: CONTACT

Phone: 15821960839

Email: [email protected]

Facility Contacts

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Shaohui Wu

Role: primary

Other Identifiers

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ITAD-PAF

Identifier Type: -

Identifier Source: org_study_id