Ezetimibe for Arrhythmia Recurrence After AF Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ezetimibe, Standardized post-ablation clinical management.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Post-Catheter Ablation Atrial Arrhythmia Recurrence. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study
Overview
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
- Drug Ezetimibe
Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation. - Other Standardized post-ablation clinical management
Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification
Primary outcome measures
- Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation [Time frame: 6 months post-ablation]
Secondary outcome measures (9)
- Early recurrence within blanking period: [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 [Time frame: 6 months post-ablation]
- Changes in blood lipid levels from baseline [Time frame: 6 months post-ablation]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07752758 · 2026-0744