Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial
Ying Lin,
Xian Wang,
Xue-Bin Li,
Bang-Qi Wu,
Zhao-Hui Zhang,
Wei-Hua Guo,
Cun-Cao Wu,
Xin Chen,
Ming-Long Chen,
Zhong Dai,
Fu-Yan Chen,
Rui Zhu,
Chu-Xi Liang,
Yun-Peng Tian,
Gang Yang,
Chao-Qun Yan,
Jing Lu,
Hai-Ying Wang,
Jin-Ling Li,
Jian-Feng Tu,
He-Wen Li,
Dan-Dan Yang,
Fang-Ting Yu,
Yu Wang,
Jing-Wen Yang,
Guang-Xia Shi,
Shi-Yan Yan,
Li-Qiong Wang,
Cun-Zhi Liu
Affiliations
Ying Lin
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Xian Wang
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing University Cardiology Research Institute of Traditional Chinese Medicine
Xue-Bin Li
Department of Cardiology, Peking University People’s Hospital
Bang-Qi Wu
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine
Zhao-Hui Zhang
Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Nanjing Medical University
Wei-Hua Guo
Department of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Cun-Cao Wu
Department of Cardiology, Peking University People’s Hospital
Xin Chen
Department of Cardiology, Tianjin First Center Hospital
Ming-Long Chen
Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
Zhong Dai
Department of Traditional Chinese Medicine, Peking University People’s Hospital
Fu-Yan Chen
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine
Rui Zhu
Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Nanjing Medical University
Chu-Xi Liang
Department of Traditional Chinese Medicine, Peking University People’s Hospital
Yun-Peng Tian
Department of Cardiology, Tianjin First Center Hospital
Gang Yang
Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
Chao-Qun Yan
Department of Acupuncture and Moxibustion
Jing Lu
Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Nanjing Medical University
Hai-Ying Wang
Department of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Jin-Ling Li
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Jian-Feng Tu
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
He-Wen Li
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Dan-Dan Yang
Department of Cardiology, Peking University People’s Hospital
Fang-Ting Yu
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Yu Wang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Jing-Wen Yang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Guang-Xia Shi
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Shi-Yan Yan
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Li-Qiong Wang
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Cun-Zhi Liu
Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
Abstract Background Atrial fibrillation (AF) is a common arrhythmia, which is closely related to cardiovascular morbidity and mortality. Although acupuncture is used in the treatment of AF, the evidence is insufficient. The objective of this pilot trial is to evaluate the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after catheter ablation (CA). Methods and design This will be a multi-center, 3-arm, pilot randomized controlled trial in China. Sixty patients in total will be randomly assigned to the specific acupoints group, the non-specific acupoints group, or the non-acupoints group in a 1:1:1 ratio. The whole study period is 6 months, including a 3-month treatment period and a 3-month follow-up period. All patients will receive 18 sessions of acupuncture over 12 weeks after CA and appropriate post-ablation routine treatment. The primary outcome is AF burden at 6 months after CA measured by electrocardiography patch that can carry out a 7-day continuous ambulatory electrocardiographic monitoring. The secondary outcomes include AF burden at 3 months after CA, recurrence of AF, quality of life, etc. The adverse events will also be recorded. Discussion This pilot study will contribute to evaluating the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after CA. The results will be used for the sample size calculation of a subsequent large-scale trial. Trial registration Chinese Clinical Trial Registry ChiCTR2000030576 . Registered on 7 March 2020.