Atrial Fibrillation, Post-Catheter Ablation Atrial Arrhythmia Recurrence
Conditions
Keywords
Atrial Fibrillation, Catheter Ablation, Ezetimibe, Atrial Arrhythmia Recurrence, Single-Blind RCT, Atrial Remodeling
Brief summary
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.
Interventions
DRUGEzetimibe
Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.
OTHERStandardized post-ablation clinical management
Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 years, male or female. 2. Diagnosis of persistent atrial fibrillation (AF) scheduled for first catheter ablation. 3. Able to provide written informed consent. 4. Able to comply with study follow-up and ECG monitoring requirements.
Exclusion criteria
1. Previous catheter ablation for atrial fibrillation. 2. Life expectancy \<12 months due to non-cardiac comorbidities. 3. Severe valvular heart disease requiring surgery or intervention. 4. Acute myocardial infarction or stroke within the past 3 months. 5. Current participation in another investigational drug/device study. 6. Inability to adhere to study procedures or follow-up. 7. Pregnancy or breastfeeding (female participants).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation | 6 months post-ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early recurrence within blanking period: | Within 3 months post-ablation | Recurrence of atrial tachyarrhythmia lasting ≥30 seconds within 3 months |
| Rehospitalization rate | 6 months post-ablation | — |
| Cardioversion rate | 6 months post ablation | — |
| Atrial fibrillation burden at 6 months post-ablation | 6 months post-ablation | — |
| Change in left atrial anteroposterior diameter (LAD) from baseline to month 6 | 6 months post-ablation | — |
| Change in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score | 6 months post-ablation | — |
| Composite endpoint comprising cardiovascular death, hospitalization attributable to atrial fibrillation or heart failure, cardioversion, and repeat catheter ablation | 6 months post ablation | — |
| Changes in brain injury-related biomarkers | 6 months post-ablation | Serum neurofilament light chain (sNfL, pg/mL), Serum phosphorylated tau 217 (p-Tau217, pg/mL) |
| Changes in blood lipid levels from baseline | 6 months post-ablation | Low-density lipoprotein cholesterol (LDL-C, mmol/L), Triglycerides (TG, mmol/L) |
Outcome results
None listed