Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Amiodarone Injection, Sodium Chloride Injection 0.9%.
- Кому может быть актуально
- Состояния в реестре: Atrial Fibrillation (AF). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
Обзор
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.
Вмешательства
- Препарат 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. - Препарат Sodium Chloride Injection 0.9%
Sodium chloride injection as a placebo in an amount equivalent to amiodarone injection.
Первичные конечные точки
- Recurrence of atrial arrhythmia lasting more than 30 seconds. [Срок оценки: At least 12 months of follow-up, beyond the initial 3 month blanking period]
Вторичные конечные точки (5)
- Recurrence of atrial fibrillation (AF) lasting more than 30 seconds. [Срок оценки: 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. [Срок оценки: During the 3-month blanking period after atrial fibrillation (AF) surgery]
- hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs) [Срок оценки: At least 12 months of follow-up]
- Quality of life assessment using AFEQT [Срок оценки: At least 12 months of follow-up]
- Serum drug concentrations of amiodarone and its metabolite desethylamiodarone. [Срок оценки: At 1 month and 3 months after surgery.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Shanghai Chest Hospital — Шанхай
Идентификаторы
NCT: NCT06742866 · ITAD-PAF