Acupuncture in Persistent Atrial Fibrillation

Kyung Hee University

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Sham acupuncture; Procedure: Active Acupuncture; Drug: flecainide

Study type: Interventional

Funder types: Other

Identifiers

NCT02110537

HI13C0580

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Active Acupuncture + flecainide

Experimental group

Description:

The participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.

Treatment:

Drug: flecainide

Procedure: Active Acupuncture

Sham acupuncture + flecainide

Sham Comparator group

Description:

The participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.

Treatment:

Drug: flecainide

Procedure: Sham acupuncture