https://orcid.org/0000-0002-7626-7751
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Abstract
Background
Guideline-recommended integrated care based on the ABC (Atrial fibrillation Better Care) pathway for “general” patients with atrial fibrillation (AF) improves clinical outcomes, as demonstrated in our prior mobile Atrial Fibrillation Application (mAFA)-II cluster randomized trial. The present study aims to investigate whether mAFA III-supported structured follow-up rehabilitation packages adapted to patient risk profiles and different treatment patterns (eg, for patients receiving drug treatment only, AF ablation, or left atrial appendage occlusion [LAAO]) will improve guideline adherence and reduce the risk of adverse cardiovascular events.
Methods and Analysis
In this prospective, observational mAFA III pilot cohort study, patients with AF aged ≥ 18 years will be enrolled using the mAFA III App for self-management. Assuming an annual rate of composite outcome of “ischaemic stroke or systemic embolism, all-cause death and cardiovascular hospitalization” of 29.3% for non-ABC pathway compliance compared with 20.8% for ABC pathway compliance, at least 1475 patients would be needed to detect the outcome of the A, B and C components of the ABC pathway, assuming a withdrawal rate of 20% in the first year. The primary endpoint is adherence to guidelines regarding the A, B and C components of the ABC pathway. Ancillary analyses will be performed to determine the impact of the ABC pathway using smart technologies on the outcomes among the “high-risk” population (eg, ≥75 years old, with multimorbidities, with polypharmacy) and the application of artificial intelligence machine-learning AF risk prediction management in assessing AF recurrence. The individualised anticoagulants with AF burden will be monitored by smart devices.
Trial Registration Number
ISRCTN13724416.
Data Sharing Statement
The data used to support the findings of this study are available from the corresponding author upon request.
Ethics Approval and Consent to Participate
The protocol for this study was approved by the Central Medical Ethics Committee of Chinese PLA General Hospital (Approval number: HZKY-PJ-2021-13), which accepted responsibility for supervising all of the aspects of the study and was also approved by local institutional review boards. All patients will provide written informed consent. The study was performed in accordance with the Declaration of Helsinki document on human research ethics. Study outcomes will be disseminated through conference presentations, peer-reviewed publications, the Internet and social media.
Patient and Public Involvement
Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Acknowledgments
The authors thank all of the study participants for their great effort.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
GYHL: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo. No fees are received personally.
Other authors: None declared.