Persistent Atrial Fibrillation Clinical Trial
Official title:
Clinical Trial to Evaluate the Antiarrhythmic Effects of Acupuncture for Drug Resistant Persistent Atrial Fibrillation: Randomized, Participant and Assessor Blinded, Sham-controlled, Clinical Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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