Atrial FibrillationPhase 4EAFANCT07752758
Ezetimibe for Arrhythmia Recurrence After AF Ablation
A Phase 4 study testing Ezetimibe and Standardized post-ablation clinical management in people with Atrial Fibrillation and Post-Catheter Ablation Atrial Arrhythmia Recurrence, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Post-Catheter Ablation Atrial Arrhythmia Recurrence
- What is being tested?
- Ezetimibe and Standardized post-ablation clinical management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study
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.
- Being tested
- Ezetimibe, Standardized post-ablation clinical management
- Keywords
- Atrial Fibrillation, Catheter Ablation, Ezetimibe, Atrial Arrhythmia Recurrence, Single-Blind RCT, Atrial Remodeling
- Medical subject headings
- Atrial Fibrillation, Atrial Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.
Standardized post-ablation clinical managementOther
Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe Intervention Arm | Experimental | 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. Receives: Drug: Ezetimibe; Other: Standardized post-ablation clinical management |
| Control Arm | Active comparator | 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. Receives: Other: Standardized post-ablation clinical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation
Measured: 6 months post-ablation
Secondary outcomes (9)
Early recurrence within blanking period:
Recurrence of atrial tachyarrhythmia lasting ≥30 seconds within 3 months
Measured: Within 3 months post-ablation
Rehospitalization rate
Measured: 6 months post-ablation
Cardioversion rate
Measured: 6 months post ablation
Atrial fibrillation burden at 6 months post-ablation
Measured: 6 months post-ablation
Change in left atrial anteroposterior diameter (LAD) from baseline to month 6
Measured: 6 months post-ablation
Change in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score
Measured: 6 months post-ablation
Composite endpoint comprising cardiovascular death, hospitalization attributable to atrial fibrillation or heart failure, cardioversion, and repeat catheter ablation
Measured: 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)
Measured: 6 months post-ablation
Changes in blood lipid levels from baseline
Low-density lipoprotein cholesterol (LDL-C, mmol/L), Triglycerides (TG, mmol/L)
Measured: 6 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752758
- Sponsor's protocol ID
- 2026-0744
- Acronym
- EAFA
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07752758
- Acronym / sponsor ID
- EAFA / 2026-0744
- Keywords
- Atrial Fibrillation, Catheter Ablation, Ezetimibe, Atrial Arrhythmia Recurrence, Single-Blind RCT, Atrial Remodeling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe Intervention Arm | Experimental | Drug: Ezetimibe, Other: Standardized post-ablation clinical managementParticipants 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. |
| Control Arm | Active comparator | Other: Standardized post-ablation clinical managementParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EzetimibeOral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation. | Drug | Ezetimibe Intervention Arm |
| Standardized post-ablation clinical managementAnticoagulation therapy, heart rate control, and cardiovascular risk factor modification | Other | Control Arm, Ezetimibe Intervention Arm |
Primary outcome
Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation
Time frame: 6 months post-ablation
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ezetimibe and Standardized post-ablation clinical management in people with Atrial Fibrillation and Post-Catheter Ablation Atrial Arrhythmia Recurrence, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation (time frame: 6 months post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.