title: Acupuncture antiarrhythmic effects on drug refractory persistent atrial fibrillation: study protocol for a randomized, controlled trial.
abstract: Background. Atrial fibrillation (AF) is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF). Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA) and left atrial appendage (LAA) changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs) of Kyung Hee University Hospital (number 1335-04). This trial is registered with clinicaltrials.gov NCT02110537.
authors.affiliation: Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Jimin
authors.initials: J
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Hyun Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Seung Min
authors.initials: SM
authors.lastname: Lee
authors.affiliation: Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Kanghyun
authors.initials: K
authors.lastname: Yoon
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Woo-Shik
authors.initials: WS
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Jong Shin
authors.initials: JS
authors.lastname: Woo
authors.affiliation: Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Sanghoon
authors.initials: S
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Jin-Bae
authors.initials: JB
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
authors.forename: Weon
authors.initials: W
authors.lastname: Kim