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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
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.
Kyung Hee University Medical Center
Seoul, Dongdaemun-gu, South Korea
RECRUITINGRecurrence 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.
Time frame: 3 months after electrical cardioversion
Changes in function and volume of left atrium and left atrial appendage evaluated by echocardiography
Time frame: 3 months after electrical cardioversion
Change of inflammation marker (hsCRP)
Other markers can be added
Time frame: 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.
Time frame: 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.
Time frame: 3 months later after electrical cardioversion
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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.