Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial
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 ef...
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| Format: | Article |
| Language: | English |
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BMC
2021-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-020-04967-y |
| _version_ | 1818453327313108992 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Ying Lin |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T21:37:13Z |
| format | Article |
| id | doaj.art-65c247ce872f4848b46ad7c5f8730e7c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T21:37:13Z |
| publishDate | 2021-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-65c247ce872f4848b46ad7c5f8730e7c2022-12-21T22:46:33ZengBMCTrials1745-62152021-01-012211910.1186/s13063-020-04967-yAcupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trialYing Lin0Xian Wang1Xue-Bin Li2Bang-Qi Wu3Zhao-Hui Zhang4Wei-Hua Guo5Cun-Cao Wu6Xin Chen7Ming-Long Chen8Zhong Dai9Fu-Yan Chen10Rui Zhu11Chu-Xi Liang12Yun-Peng Tian13Gang Yang14Chao-Qun Yan15Jing Lu16Hai-Ying Wang17Jin-Ling Li18Jian-Feng Tu19He-Wen Li20Dan-Dan Yang21Fang-Ting Yu22Yu Wang23Jing-Wen Yang24Guang-Xia Shi25Shi-Yan Yan26Li-Qiong Wang27Cun-Zhi Liu28Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing University Cardiology Research Institute of Traditional Chinese MedicineDepartment of Cardiology, Peking University People’s HospitalNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital, Tianjin University of Traditional Chinese MedicineDepartment of Acupuncture and Moxibustion, The First Affiliated Hospital of Nanjing Medical UniversityDepartment of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese MedicineDepartment of Cardiology, Peking University People’s HospitalDepartment of Cardiology, Tianjin First Center HospitalDepartment of Cardiology, The First Affiliated Hospital of Nanjing Medical UniversityDepartment of Traditional Chinese Medicine, Peking University People’s HospitalNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital, Tianjin University of Traditional Chinese MedicineDepartment of Acupuncture and Moxibustion, The First Affiliated Hospital of Nanjing Medical UniversityDepartment of Traditional Chinese Medicine, Peking University People’s HospitalDepartment of Cardiology, Tianjin First Center HospitalDepartment of Cardiology, The First Affiliated Hospital of Nanjing Medical UniversityDepartment of Acupuncture and MoxibustionDepartment of Acupuncture and Moxibustion, The First Affiliated Hospital of Nanjing Medical UniversityDepartment of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese MedicineAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical UniversityAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineDepartment of Cardiology, Peking University People’s HospitalAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAcupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAbstract 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.https://doi.org/10.1186/s13063-020-04967-yAcupunctureAtrial fibrillation burdenCatheter ablationPersistent atrial fibrillationRandomized controlled trial |
| spellingShingle | 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 Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial Trials Acupuncture Atrial fibrillation burden Catheter ablation Persistent atrial fibrillation Randomized controlled trial |
| title | Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial |
| title_full | Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial |
| title_fullStr | Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial |
| title_full_unstemmed | Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial |
| title_short | Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial |
| title_sort | acupuncture for persistent atrial fibrillation after catheter ablation study protocol for a pilot randomized controlled trial |
| topic | Acupuncture Atrial fibrillation burden Catheter ablation Persistent atrial fibrillation Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-020-04967-y |
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