NCT07752758Not yet recruitingPhase 4
Ezetimibe for Arrhythmia Recurrence After AF Ablation
Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 15 Aug 2026
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Atrial fibrillation
- NCT number
- NCT07752758
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 15 Aug 2026 to the primary completion date, 1 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous catheter ablation for atrial fibrillation.
- Current participation in another investigational drug/device study.
Other illness
- 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.
Other
- Inability to adhere to study procedures or follow-up.
- Pregnancy or breastfeeding (female participants).
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.