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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.
Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification
Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation
Time frame: 6 months post-ablation
Early recurrence within blanking period:
Recurrence of atrial tachyarrhythmia lasting ≥30 seconds within 3 months
Time frame: Within 3 months post-ablation
Rehospitalization rate
Time frame: 6 months post-ablation
Cardioversion rate
Time frame: 6 months post ablation
Atrial fibrillation burden at 6 months post-ablation
Time frame: 6 months post-ablation
Change in left atrial anteroposterior diameter (LAD) from baseline to month 6
Time frame: 6 months post-ablation
Change in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score
Time frame: 6 months post-ablation
Composite endpoint comprising cardiovascular death, hospitalization attributable to atrial fibrillation or heart failure, cardioversion, and repeat catheter ablation
Time frame: 6 months post ablation
Changes in brain injury-related biomarkers
Serum neurofilament light chain (sNfL, pg/mL), Serum phosphorylated tau 217 (p-Tau217, pg/mL)
Time frame: 6 months post-ablation
Changes in blood lipid levels from baseline
Low-density lipoprotein cholesterol (LDL-C, mmol/L), Triglycerides (TG, mmol/L)
Time frame: 6 months post-ablation
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