Atrial Fibrillation (AF)NCT07487532
Acupuncture for Preventing Atrial Arrhythmia Recurrence After Ablation
A study testing Electroacupuncture and Standard Medical Therapy in people with Atrial Fibrillation (AF), run by Shanghai Zhongshan Hospital.
Trial summary
This study aims to evaluate whether acupuncture can reduce the recurrence of atrial arrhythmias after catheter ablation in patients with persistent atrial fibrillation. Catheter ablation is an effective treatment for atrial fibrillation, but recurrence remains common, especially in persistent cases. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Electroacupuncture and Standard Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Apr 2028
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 75 years
- Persistent atrial fibrillation
- Undergoing first-time catheter ablation with successful restoration of sinus rhythm
- Left atrial diameter <50 mm
- Able to understand the study and provide written informed consent
Who cannot join
- Cardiovascular events within the past 3 months (including stroke, transient ischemic attack, myocardial infarction, unstable angina, or cardiac surgery)
- Symptomatic hypotension with systolic blood pressure <100 mmHg on two consecutive measurements
- Severe valvular heart disease or other significant structural heart disease
- Pregnancy, breastfeeding, or planned pregnancy during the study period
- History of pacemaker implantation
- Second- or third-degree atrioventricular block
Show all 20Show fewer
- Bifascicular or trifascicular block
- Acupuncture treatment for cardiovascular disease within the past 3 months
- Severe comorbid conditions, including:
- Malignant tumors
- Chronic infectious diseases
- Severe renal dysfunction (eGFR <30 mL/min/1.73 m² or requiring dialysis)
- Moderate to severe liver dysfunction (Child-Pugh class B or C)
- Anemia (hemoglobin <90 g/L)
- Systemic diseases requiring steroid therapy
- Severe cognitive impairment or dementia
- Alcohol or substance abuse
- Life expectancy <12 months
- Poor compliance or inability to provide informed consent
- Participation in another interventional clinical study
About this study
Official title: Effectiveness of Acupuncture for Atrial Tachyarrhythmia Prevention After Catheter Ablation in Persistent Atrial Fibrillation Patients: a Prospective, Open-label, Randomized, Blank-controlled Trial
This study aims to evaluate whether acupuncture can reduce the recurrence of atrial arrhythmias after catheter ablation in patients with persistent atrial fibrillation. Catheter ablation is an effective treatment for atrial fibrillation, but recurrence remains common, especially in persistent cases.
In this prospective, randomized, open-label trial, 120 patients with persistent atrial fibrillation who have undergone successful catheter ablation will be enrolled and randomly assigned to two groups. The intervention group will receive acupuncture in addition to standard medical therapy, while the control group will receive standard medical therapy alone.
Read more
Participants will be followed for 12 months. The primary outcome is the recurrence of atrial arrhythmias, including atrial fibrillation, atrial flutter, or atrial tachycardia. Secondary outcomes include cardiac structure and function, atrial fibrillation burden, and quality of life.
This study will provide clinical evidence on whether acupuncture can be an effective adjunctive therapy to improve outcomes after catheter ablation.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Electroacupuncture, Standard Medical Therapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Electroacupuncture is administered starting on the second day after catheter ablation. Treatment is performed twice weekly for 5 weeks using bilateral Neiguan (PC6) and Jianshi (PC5) acupoints. Low-frequency electrical stimulation (2 Hz) is applied during each session. All procedures are performed by trained practitioners following standardized protocols.
Standard Medical TherapyDrug
Standard medical therapy is administered after catheter ablation according to current clinical guidelines and physician judgment. This includes antiarrhythmic drugs and anticoagulation therapy as appropriate. Medication use is recorded throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Plus Standard Therapy | Experimental | Not described Receives: Procedure: Electroacupuncture |
| Standard Therapy Alone | Active comparator | Not described Receives: Drug: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Atrial Arrhythmia After Catheter Ablation
Recurrence of atrial arrhythmia, defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period, detected by 12-lead electrocardiogram or 24-hour Holter monitoring and adjudicated by blinded electrophysiologists.
Measured: Up to 12 months after catheter ablation (excluding a 3-month blanking period)
Secondary outcomes (6)
Change in Left Atrial Diameter
Measured: Baseline and 12 months after catheter ablation
Change in Left Ventricular End-Diastolic Diameter
Measured: Baseline and 12 months after catheter ablation
Change in Left Ventricular End-Systolic Diameter
Measured: Baseline and 12 months after catheter ablation
Change in Left Ventricular Ejection Fraction
Measured: Baseline and 12 months after catheter ablation
Change in Atrial Fibrillation Burden
Measured: Baseline and 12 months after catheter ablation
Change in Atrial Fibrillation Effect on Quality-of-Life Questionnaire overall score
AFEQT is a 20-item atrial fibrillation-specific quality-of-life questionnaire. Scores range from 0 to 100, with higher scores indicating better health status / better quality of life.
Measured: Baseline, and 1, 3, 6, and 12 months after catheter ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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 N/A
- 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
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487532
- Sponsor's protocol ID
- B2026-077
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture for Atrial Tachyarrhythmia Prevention After Catheter Ablation in Persistent Atrial Fibrillation Patients: a Prospective, Open-label, Randomized, Blank-controlled Trial
- ClinicalTrials.gov ID
- NCT07487532
- Acronym / sponsor ID
- B2026-077
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 23 Mar 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 study aims to evaluate whether acupuncture can reduce the recurrence of atrial arrhythmias after catheter ablation in patients with persistent atrial fibrillation. Catheter ablation is an effective treatment for atrial fibrillation, but recurrence remains common, especially in persistent cases.
In this prospective, randomized, open-label trial, 120 patients with persistent atrial fibrillation who have undergone successful catheter ablation will be enrolled and randomly assigned to two groups. The intervention group will receive acupuncture in addition to standard medical therapy, while the control group will receive standard medical therapy alone.
Participants will be followed for 12 months. The primary outcome is the recurrence of atrial arrhythmias, including atrial fibrillation, atrial flutter, or atrial tachycardia. Secondary outcomes include cardiac structure and function, atrial fibrillation burden, and quality of life.
This study will provide clinical evidence on whether acupuncture can be an effective adjunctive therapy to improve outcomes after 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 |
|---|---|---|
| Acupuncture Plus Standard Therapy | Experimental | Procedure: Electroacupuncture |
| Standard Therapy Alone | Active comparator | Drug: Standard Medical Therapy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20 to 75 years
- Persistent atrial fibrillation
- Undergoing first-time catheter ablation with successful restoration of sinus rhythm
- Left atrial diameter <50 mm
- Able to understand the study and provide written informed consent
Key exclusion criteria (20 listed)
- Cardiovascular events within the past 3 months (including stroke, transient ischemic attack, myocardial infarction, unstable angina, or cardiac surgery)
- Symptomatic hypotension with systolic blood pressure <100 mmHg on two consecutive measurements
- Severe valvular heart disease or other significant structural heart disease
- Pregnancy, breastfeeding, or planned pregnancy during the study period
- History of pacemaker implantation
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 |
|---|---|---|
| ElectroacupunctureElectroacupuncture is administered starting on the second day after catheter ablation. Treatment is performed twice weekly for 5 weeks using bilateral Neiguan (PC6) and Jianshi (PC5) acupoints. Low-frequency electrical stimulation (2 Hz) is applied during each session. All procedures are performed by trained practitioners following standardized protocols. | Procedure or surgery | Acupuncture Plus Standard Therapy |
| Standard Medical TherapyStandard medical therapy is administered after catheter ablation according to current clinical guidelines and physician judgment. This includes antiarrhythmic drugs and anticoagulation therapy as appropriate. Medication use is recorded throughout the study period. | Drug | Standard Therapy Alone |
Primary outcome
Recurrence of Atrial Arrhythmia After Catheter Ablation
Time frame: Up to 12 months after catheter ablation (excluding a 3-month blanking period)
Recurrence of atrial arrhythmia, defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period, detected by 12-lead electrocardiogram or 24-hour Holter monitoring and adjudicated by blinded electrophysiologists.
6 secondary outcomes
Change in Left Atrial Diameter
Time frame: Baseline and 12 months after catheter ablation
Change in Left Ventricular End-Diastolic Diameter
Time frame: Baseline and 12 months after catheter ablation
Change in Left Ventricular End-Systolic Diameter
Time frame: Baseline and 12 months after catheter ablation
Change in Left Ventricular Ejection Fraction
Time frame: Baseline and 12 months after catheter ablation
Change in Atrial Fibrillation Burden
Time frame: Baseline and 12 months after catheter ablation
Change in Atrial Fibrillation Effect on Quality-of-Life Questionnaire overall score
Time frame: Baseline, and 1, 3, 6, and 12 months after catheter 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 1 Apr 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 study testing Electroacupuncture and Standard Medical Therapy in people with Atrial Fibrillation (AF), run by Shanghai Zhongshan Hospital.
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 5 inclusion and 20 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 1 Apr 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.
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 Arrhythmia After Catheter Ablation (time frame: Up to 12 months after catheter ablation (excluding a 3-month blanking period)). 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 1 Apr 2026.