Ezetimibe for Arrhythmia Recurrence After AF Ablation

Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study ID
NCT07752758
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Jun 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ezetimibe Intervention Arm
    Participants in this group will receive 10 mg of oral ezetimibe once daily for six consecutive months starting on the day of catheter ablation. Hobimibe use is strictly prohibited throughout the treatment period. All patients will receive standardized post-ablation clinical management, including anticoagulation therapy, heart rate control, and cardiovascular risk factor modification.
  • Active Comparator: Control Arm
    Participants in this arm will not receive ezetimibe or hobimibe, but will receive identical standardized post-ablation clinical management (anticoagulation, heart rate control, and risk factor modification) as the Ezetimibe Intervention Arm.

Primary Outcome Measure

Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation [ Time Frame: 6 months post-ablation ]

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