Current guidelines recommend opportunistic screening for subclinical atrial fibrillation (AF) taking advantage of e-health-based technologies. However, the efficacy of a fully scalable e-health-based strategy for AF detection in a head-to-head comparison with routine symptom-based screening is unknown. eBRAVE-AF is an investigator-initiated, digital, prospective, randomized, siteless, open-label, cross-over study to evaluate an e-health-based strategy for detection of AF in a real-world setting. 67,488 policyholders of a large German health insurance company (Versicherungskammer Bayern, Germany) selected by age ≥ 50 years and a CHA2DS2-VASc score ≥ 1 (females ≥2) are invited to participate. Subjects with known AF or on treatment with oral anticoagulation are excluded. After obtaining electronic informed consent, at least 4,400 participants will be randomly assigned to an e-health-based screening strategy or routine symptom-based screening. The e-health-based strategy consists of repetitive one-minute photoplethysmographic (PPG) pulse wave assessments using a certified smartphone app (Preventicus Heartbeats, Preventicus, Jena, Germany), followed by a confirmatory 14-day ECG patch (CardioMem CM 100 XT, Getemed, Teltow, Germany) in case of abnormal findings. After 6 months, participants are crossed over to the other study arm. Primary endpoint is the incidence of newly diagnosed AF leading to oral anticoagulation indicated by an independent physician. Clinical follow-up will be at least 12 months. In both groups, follow-up is performed by 4-week app-based questionnaires, personal contact in case of abnormal findings, and matching with claim-based insurance data and medical reports. At time of writing enrollment is completed. First results are expected to be available in mid-2021.

中文翻译：

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使用智能手机检测高危人群亚临床房颤的数字试验的原理和设计：基于 eHealth 的巴伐利亚房颤替代检测 (eBRAVE-AF) 试验。

目前的指南建议利用基于电子健康的技术对亚临床心房颤动 (AF) 进行机会性筛查。然而，在与常规基于症状的筛查进行头对头比较时，完全可扩展的基于电子健康的 AF 检测策略的功效尚不清楚。eBRAVE-AF 是一项由研究者发起的、数字化、前瞻性、随机化、无站点、开放标签、交叉研究，用于评估基于电子健康的策略，用于在现实环境中检测 AF。邀请年龄≥50岁且CHA2DS2-VASc评分≥1（女性≥2）的德国大型健康保险公司（Versicherungskammer Bayern，德国）的67,488名投保人参加。排除已知 AF 或接受口服抗凝治疗的受试者。获得电子知情同意后，至少 4，400 名参与者将被随机分配到基于电子健康的筛查策略或基于症状的常规筛查。基于电子健康的策略包括使用经过认证的智能手机应用程序（Preventicus Heartbeats，Preventicus，Jena，德国）进行重复的一分钟光体积描记 (PPG) 脉搏波评估，然后是验证性的 14 天心电图贴片 (CardioMem CM 100 XT) , Getemed, Teltow, Germany)，以防发现异常。6 个月后，参与者被转移到另一个研究组。主要终点是新诊断的 AF 导致独立医生指示的口服抗凝剂的发生率。临床随访将至少为 12 个月。在两组中，通过为期 4 周的基于应用程序的问卷调查进行随访，如果发现异常，则进行个人联系，并与基于索赔的保险数据和医疗报告相匹配。在撰写本文时，注册已完成。预计第一个结果将在 2021 年中期公布。