Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.
Division of Cardiology, Department of Medicine, University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA 94143, USA.
Europace. 2024 Jul 2;26(7). doi: 10.1093/europace/euae189.
Wearable cardioverter-defibrillators (WCDs) are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating ventricular tachycardia/ventricular fibrillation (VT/VF) with a single shock. The aim was to evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD.
This was a first-in-human, prospective, single-arm, single-centre study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150 J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events.
This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF.
URL: https://clinicaltrials.gov/; Unique identifier: NCT05490459.
可穿戴式除颤器 (WCD) 适用于存在心搏骤停风险但并非立即植入除颤器治疗适应证的患者。现有 WCD 的局限性包括患者顺应性差和高假警报率。Jewel 是一种新型贴片式 WCD (P-WCD)，采用基于粘性的设计实现近乎连续佩戴，并采用机器学习算法最大限度地减少不适当的检测，从而解决了这些局限性。这是 Jewel P-WCD 在电生理 (EP) 实验室中进行的首次人体研究，旨在确定单次电击终止室性心动过速/心室颤动 (VT/VF) 的设备安全性和有效性。目的是评估使用 Jewel P-WCD 单次电击终止 VT/VF 的安全性和有效性。
这是一项首次人体、前瞻性、单臂、单中心研究，纳入计划进行 EP 程序的患者，预计 VT/VF 会自发发生或通过诱导发生。将 Jewel P-WCD 放置在同意的患者身上；确认 VT/VF 后，通过设备给予单次电击（150J）。采用群组序贯设计和 Pocock α 花费函数来衡量单次电击成功终止 VT/VF 的观察比例。如果置信下限大于性能目标 62%，则使用单侧下 97.4%精确置信限达到终点。在 18 名符合条件的受试者中，16 名（88.9%，97.4%置信限：65.4%）通过单次电击成功除颤，达到了主要终点的性能目标，且无不良事件发生。
Jewel P-WCD 的首次人体评估证明了终止 VT/VF 的安全性和有效性。
