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Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized
Ying Lin1, Xian Wang2, Xue-Bin Li3
1Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Insights
This pilot study investigates acupuncture for persistent atrial fibrillation (AF) after catheter ablation. It assesses feasibility, efficacy, and safety, aiming to inform larger trials on reducing AF burden.
Area of Science:
- Cardiology
- Integrative Medicine
- Clinical Trials
Background:
- Atrial fibrillation (AF) is a prevalent arrhythmia linked to significant cardiovascular risks.
- Current evidence on acupuncture for AF treatment is limited.
- Persistent AF after catheter ablation (CA) warrants further investigation for novel therapeutic approaches.
Purpose of the Study:
- To evaluate the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden in patients with persistent AF post-CA.
- To gather data for sample size calculation in future large-scale randomized controlled trials.
Main Methods:
- A multi-center, 3-arm pilot randomized controlled trial involving 60 patients in China.
- Participants were randomized to specific acupoints, non-specific acupoints, or no acupoints groups (1:1:1 ratio).
- A 6-month study period with a 3-month treatment phase (18 acupuncture sessions over 12 weeks) and a 3-month follow-up, alongside standard post-ablation care.
Main Results:
- Primary outcome: AF burden at 6 months post-CA, measured by 7-day continuous ambulatory electrocardiographic monitoring.
- Secondary outcomes: AF burden at 3 months, AF recurrence rates, and quality of life.
- Adverse events were systematically recorded throughout the study.
Conclusions:
- This pilot study provides crucial data on the feasibility, preliminary efficacy, and safety of acupuncture for persistent AF after CA.
- Findings will guide the design and sample size determination for subsequent large-scale clinical trials on acupuncture's role in managing AF.
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.
