Ezetimibe for Arrhythmia Recurrence After AF Ablation

Официальное название

Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study

Обзор

This single-center, prospective, single-blind randomized controlled pilot trial aims to explore whether oral ezetimibe can reduce the 6-month recurrence rate of atrial tachyarrhythmia after catheter ablation in patients with persistent atrial fibrillation. A total of 120 eligible patients will be randomized at a 1:1 ratio into the ezetimibe group and the control group within 24 hours after ablation. Stratified randomization based on body mass index (BMI) and left atrial diameter will be performed via an interactive web response system (IWRS). This study adopts a single-blind design: patients and investigators are unblinded to group allocation, whereas an independent Endpoint Adjudication Committee consisting of three electrophysiologists will blindly review all ECG data to determine arrhythmia recurrence. The intervention group will receive 10 mg oral ezetimibe once daily for six months following ablation, and the use of hobimibe is prohibited in this group. The control group will refrain from the use of both ezetimibe and hobimibe, with standardized postoperative management maintained consistently across the two groups. The primary endpoint is the recurrence of atrial tachyarrhythmia lasting ≥30 seconds after the blanking period within six months post-ablation. Secondary endpoints include early atrial tachyarrhythmia recurrence, atrial fibrillation burden, changes in left atrial diameter, quality of life scores, and composite cardiovascular events. Safety outcomes encompass hepatic and muscular adverse reactions as well as serious adverse events. This prospective pilot study will provide preliminary clinical evidence for optimizing rhythm control strategies after atrial fibrillation catheter ablation.

Вмешательства

• Препарат Ezetimibe
  Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.
• Другое Standardized post-ablation clinical management
  Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification

Первичные конечные точки

• Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation [Срок оценки: 6 months post-ablation]

Вторичные конечные точки (9)

• Early recurrence within blanking period: [Срок оценки: Within 3 months post-ablation]
• Rehospitalization rate [Срок оценки: 6 months post-ablation]
• Cardioversion rate [Срок оценки: 6 months post ablation]
• Atrial fibrillation burden at 6 months post-ablation [Срок оценки: 6 months post-ablation]
• Change in left atrial anteroposterior diameter (LAD) from baseline to month 6 [Срок оценки: 6 months post-ablation]
• Change in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score [Срок оценки: 6 months post-ablation]
• Composite endpoint comprising cardiovascular death, hospitalization attributable to atrial fibrillation or heart failure, cardioversion, and repeat catheter ablation [Срок оценки: 6 months post ablation]
• Changes in brain injury-related biomarkers [Срок оценки: 6 months post-ablation]
• Changes in blood lipid levels from baseline [Срок оценки: 6 months post-ablation]

Критерии участия

Критерии включения

• Age 18 to 80 years, male or female.
• Diagnosis of persistent atrial fibrillation (AF) scheduled for first catheter ablation.
• Able to provide written informed consent.
• Able to comply with study follow-up and ECG monitoring requirements.

Критерии исключения

• Previous catheter ablation for atrial fibrillation.
• Life expectancy <12 months due to non-cardiac comorbidities.
• Severe valvular heart disease requiring surgery or intervention.
• Acute myocardial infarction or stroke within the past 3 months.
• Current participation in another investigational drug/device study.
• Inability to adhere to study procedures or follow-up.
• Pregnancy or breastfeeding (female participants).

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07752758 · 2026-0744

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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