Acupuncture in Persistent Atrial Fibrillation
Clinical Trial to Evaluate the Antiarrhythmic Effects of Acupuncture for Drug Resistant Persistent Atrial Fibrillation: Randomized, Participant and Assessor Blinded, Sham-controlled, Clinical Trial
1 other identifier
interventional
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 6, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 10, 2014
April 1, 2014
1.3 years
April 6, 2014
April 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Number of Participants with Adverse Events (AEs)
Participants will be followed for the duration of this study, an expected average 14 weeks
the factor to make atrial fibrillation recur
3 months later after electrical cardioversion
Study Arms (2)
Active Acupuncture + flecainide
EXPERIMENTALThe participants in this group receive verum acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
Sham acupuncture + flecainide
SHAM COMPARATORThe participants in this group receive sham acupuncture treatment once a week for 10 weeks and flecainide 75 mg twice daily.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Persistent AF lasting ≥ 7 days
- Ages in 20-75 years
- Resistant with antiarrhythmic drugs
- Written informed consent
You may not qualify if:
- 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
- nd degree atrioventricular block or more than two fascicular block
- Severe pulmonary, liver, or renal disease
- Previous acupuncture treatment for cardiovascular condition within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University Medical Center
Seoul, Dongdaemun-gu, 130-701, South Korea
Related Publications (2)
Lee SM, Leem J, Park JH, Yoon KH, Woo JS, Lee JM, Kim JB, Kim W, Lee S. Close look at the experiences of patients enrolled in a clinical trial of acupuncture treatment for atrial fibrillation in Korea: a qualitative study nested within a randomised controlled trial. BMJ Open. 2017 Feb 3;7(2):e013180. doi: 10.1136/bmjopen-2016-013180.
PMID: 28159849DERIVEDPark J, Kim HS, Lee SM, Yoon K, Kim WS, Woo JS, Lee S, Kim JB, Kim W. Acupuncture antiarrhythmic effects on drug refractory persistent atrial fibrillation: study protocol for a randomized, controlled trial. Evid Based Complement Alternat Med. 2015;2015:613970. doi: 10.1155/2015/613970. Epub 2015 Feb 17.
PMID: 25784948DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weon Kim, Professor
Kyunghee University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 6, 2014
First Posted
April 10, 2014
Study Start
March 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
April 10, 2014
Record last verified: 2014-04