A Phase 4 interventional study of Ezetimibe and Standardized post-ablation clinical management in Atrial Fibrillation and Post-Catheter Ablation Atrial Arrhythmia Recurrence, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 4, Interventional, and Treatment
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 120 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 99 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ezetimibe · Other: Standardized post-ablation clinical management
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.
Other: Standardized post-ablation clinical management
Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.
Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification
Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation
Time frame: 6 months post-ablation
Early recurrence within blanking period:
Recurrence of atrial tachyarrhythmia lasting ≥30 seconds within 3 months
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
Serum neurofilament light chain (sNfL, pg/mL), Serum phosphorylated tau 217 (p-Tau217, pg/mL)
Time frame: 6 months post-ablation
Changes in blood lipid levels from baseline
Low-density lipoprotein cholesterol (LDL-C, mmol/L), Triglycerides (TG, mmol/L)
Time frame: 6 months post-ablation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jun 2028, 21 months later.
Of 129 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 81. This study's planned 21 months is below that.
Counting every sponsor, half of 141 studies reached it within 48 months; a quarter within 27 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ezetimibe
Second Affiliated Hospital, Zhejiang University, School of Medicine