Persistent Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Acupuncture, Recurrence, Electrical cardioversion
Brief summary
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
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.
Interventions
PROCEDUREActive Acupuncture
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.
PROCEDURESham acupuncture
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.
DRUGflecainide
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.
Sponsors
Ministry of Health & Welfare, Korea
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial fibrillation evaluated on serial electrocardiography and 48 hour holter monitoring after sinus conversion by electrical cardioversion | 3 months after 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 3 months after electrical cardioversion | Other markers can be added |
| Number of Participants with Adverse Events (AEs) | Participants will be followed for the duration of this study, an expected average 14 weeks | 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. |
| the factor to make atrial fibrillation recur | 3 months later after electrical cardioversion | we will perform multivariate regression analysis to know which factor makes atrial fibrillation recur irrespective of intervention method. |
Countries
South Korea
Contacts
Primary ContactWeon Kim, Professor
Outcome results
None listed