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NCT Number: NCT07752758

Ezetimibe for Arrhythmia Recurrence After AF Ablation

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ezetimibe

Drug

Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.

Standardized post-ablation clinical management

Other

Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification

Primary outcomes

  1. Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation

    Time frame: 6 months post-ablation

Secondary outcomes

  1. Early recurrence within blanking period:

    Time frame: Within 3 months post-ablation

    Recurrence of atrial tachyarrhythmia lasting ≥30 seconds within 3 months

  2. Rehospitalization rate

    Time frame: 6 months post-ablation

  3. Cardioversion rate

    Time frame: 6 months post ablation

  4. Atrial fibrillation burden at 6 months post-ablation

    Time frame: 6 months post-ablation

  5. Change in left atrial anteroposterior diameter (LAD) from baseline to month 6

    Time frame: 6 months post-ablation

  6. Change in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score

    Time frame: 6 months post-ablation

  7. Composite endpoint comprising cardiovascular death, hospitalization attributable to atrial fibrillation or heart failure, cardioversion, and repeat catheter ablation

    Time frame: 6 months post ablation

  8. Changes in brain injury-related biomarkers

    Time frame: 6 months post-ablation

    Serum neurofilament light chain (sNfL, pg/mL), Serum phosphorylated tau 217 (p-Tau217, pg/mL)

  9. Changes in blood lipid levels from baseline

    Time frame: 6 months post-ablation

    Low-density lipoprotein cholesterol (LDL-C, mmol/L), Triglycerides (TG, mmol/L)

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Registry information

Official study title

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

Acronym: EAFA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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