Acupuncture in Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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The aim of this trial is to evaluate the effect of acupuncture on prevention of atrial fibrillation (AF) recurrence after electrical cardioversion (EC) for persistent AF patients resistant to the antiarrhythmic drugs (AADs).

Detailed Description
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This is a multicenter, prospective, participant and assessor blinded, randomized, sham-controlled clinical trial with 2 parallel arms. To evaluate the efficacy and safety of acupuncture, a total of 80 persistent AF participants will be recruited and randomly assigned to active acupuncture and sham acupuncture group. Both group commonly take antiarrhythmic medication during study period. These patients who are resistant to drug therapy will get a electrical cardioversion. After cardioversion, the recurrence rate and duration of atrial fibrillation free time will be evaluated. This trial consists of 2 weeks of observation and medical therapy, 2 weeks of acupuncture intervention before EC, EC and acupuncture intervention, 7 weeks of additional intervention, and 5 weeks of follow-up. After randomization, participants receive 10 sessions of acupuncture treatments over 10 weeks. The outcome is assessed at 2, 4, 6, 8, and 16 week after randomization.

Official Title
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Clinical Trial to Evaluate the Antiarrhythmic Effects of Acupuncture for Drug Resistant Persistent Atrial Fibrillation: Randomized, Participant and Assessor Blinded, Sham-controlled, Clinical Trial

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Active Acupuncture
* Procedure: Sham acupuncture
* Drug: flecainide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent AF lasting ≥ 7 days Ages in 20-75 years Resistant with antiarrhythmic drugs Written informed consent Exclusion Criteria: Age below 20 years or above 75 years Severe valvular heart disease History of open heart surgery History of treatment for myocardial infarction (MI) within recent 6 weeks Patients under or requiring the administration of antiviral drugs 2nd degree atrioventricular block or more than two fascicular block Severe pulmonary, liver, or renal disease Previous acupuncture treatment for cardiovascular condition within 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Acupuncture + flecainide<br>The participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily. | Procedure: Active Acupuncture<br>* Active acupuncture treatment group consists of electroacupuncture (EA) and intradermal acupuncture (IDA). For EA treatment, unilateral PC5, PC6, ST36, and ST37 are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2 ± 0.5 cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2Hz, continuous wave current for 20 minutes. For IDA treatment, bilateral HT7 and TF4 are selected. Disposable, sterile, sticker-type needles (0.18 mm x 1.3 mm x 1.5mm) are used. Attached needles are maintained as long as possible.<br>Drug: flecainide<br>* Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.<br>* Other names: tambocor;|
| Sham Comparator: Sham acupuncture + flecainide<br>The participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily. | Procedure: Sham acupuncture<br>* For sham intervention, nonacupuncture points are used. As with active treatment group, two types of acupuncture, sham EA and sham IDA, compose the sham intervention. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.<br>Drug: flecainide<br>* Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.<br>* Other names: tambocor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation evaluated on serial electrocardiography and 48 hour holter monitoring after sinus conversion by electrical cardioversion | When patient feel symptoms such as palpitation and chest discomfort, the patients are recommended to visit hospital to check out the recurrence of atrial fibrillation. | 3 months after electrical cardioversion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in function and volume of left atrium and left atrial appendage evaluated by echocardiography |  | 3 months after electrical cardioversion | 
| Change of inflammation marker (hsCRP) | Other markers can be added | 3 months after electrical cardioversion | 
| Number of Participants with Adverse Events (AEs) | All participants and practitioners are taught to report any AEs. If there are any AEs, the following items are recorded by practitioners at each visit and appropriate actions are taken: type of AEs, occurrence date, lost date, frequency of occurrence, severity, causality with the treatment, actions taken with the acupuncture intervention, and actions taken to the participants. Serious AEs, i.e. death or life-threatening events which are required urgent intervention, will be noted to the principal investigators immediately and determine whether the participants are dropped out. | Participants will be followed for the duration of this study, an expected average 14 weeks | 
| the factor to make atrial fibrillation recur | we will perform multivariate regression analysis to know which factor makes atrial fibrillation recur irrespective of intervention method. | 3 months later after electrical cardioversion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Acupuncture, Recurrence, Electrical cardioversion