{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T20:56:06Z","timestamp":1792184166754,"version":"4.4.0"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2024,7,13]],"date-time":"2024-07-13T00:00:00Z","timestamp":1720828800000},"content-version":"vor","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Element Science, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,7,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT\/VF.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trial Registration<\/jats:title>\n                  <jats:p>URL: https:\/\/clinicaltrials.gov\/; Unique identifier: NCT05490459<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/europace\/euae189","type":"journal-article","created":{"date-parts":[[2024,7,13]],"date-time":"2024-07-13T14:05:31Z","timestamp":1720879531000},"source":"Crossref","is-referenced-by-count":8,"title":["First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator"],"prefix":"10.1093","volume":"26","author":[{"given":"Milan","family":"Chovanec","sequence":"first","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Petr\u016f","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9103-5406","authenticated-orcid":false,"given":"Pavel","family":"H\u00e1la","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stepan","family":"Kralovec","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjali B","family":"Thakkar","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine, University of California San Francisco , 505 Parnassus Avenue, San Francisco, CA 94143 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1291-5042","authenticated-orcid":false,"given":"Kiran","family":"Mathews","sequence":"additional","affiliation":[{"name":"Element Science, Inc. , Redwood City, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maarten","family":"Dinger","sequence":"additional","affiliation":[{"name":"Element Science, Inc. , Redwood City, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Ullery","sequence":"additional","affiliation":[{"name":"North American Science Associates , Walnut Creek, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zubin J","family":"Eapen","sequence":"additional","affiliation":[{"name":"Element Science, Inc. , Redwood City, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uday N","family":"Kumar","sequence":"additional","affiliation":[{"name":"Element Science, Inc. , Redwood City, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4334-8165","authenticated-orcid":false,"given":"Petr","family":"Neu\u017eil","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Na Homolce Hospital , Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,7,13]]},"reference":[{"key":"2024073112222565000_euae189-B1","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1016\/j.hlc.2018.08.026","article-title":"Epidemiology of sudden cardiac death: global and regional perspectives","volume":"28","author":"Wong","year":"2019","journal-title":"Heart Lung Circ"},{"key":"2024073112222565000_euae189-B2","author":"WHO Scientific Group, WHO"},{"key":"2024073112222565000_euae189-B3","doi-asserted-by":"crossref","first-page":"1569","DOI":"10.1056\/NEJM199711273372201","article-title":"Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery. Coronary artery bypass graft (CABG) patch trial investigators","volume":"337","author":"Bigger","year":"1997","journal-title":"N Engl J Med"},{"key":"2024073112222565000_euae189-B4","doi-asserted-by":"crossref","first-page":"1933","DOI":"10.1056\/NEJM199612263352601","article-title":"Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter automatic defibrillator implantation trial investigators","volume":"335","author":"Moss","year":"1996","journal-title":"N Engl J Med"},{"key":"2024073112222565000_euae189-B5","doi-asserted-by":"crossref","first-page":"1882","DOI":"10.1056\/NEJM199912163412503","article-title":"A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter unsustained tachycardia trial investigators","volume":"341","author":"Buxton","year":"1999","journal-title":"N Engl J Med"},{"key":"2024073112222565000_euae189-B6","doi-asserted-by":"crossref","first-page":"877","DOI":"10.1056\/NEJMoa013474","article-title":"Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction","volume":"346","author":"Moss","year":"2002","journal-title":"N Engl J Med"},{"key":"2024073112222565000_euae189-B7","doi-asserted-by":"crossref","first-page":"225","DOI":"10.1056\/NEJMoa043399","article-title":"Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure","volume":"352","author":"Bardy","year":"2005","journal-title":"N Engl J Med"},{"key":"2024073112222565000_euae189-B8","doi-asserted-by":"crossref","first-page":"1715","DOI":"10.1161\/CIR.0000000000000394","article-title":"Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death","volume":"133","author":"Piccini","year":"2016","journal-title":"Circulation"},{"key":"2024073112222565000_euae189-B9","doi-asserted-by":"crossref","first-page":"1205","DOI":"10.1056\/NEJMoa1800781","article-title":"Wearable cardioverter-defibrillator after myocardial infarction","volume":"379","author":"Olgin","year":"2018","journal-title":"N Engl J Med"},{"key":"2024073112222565000_euae189-B10","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.1111\/jce.14404","article-title":"Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: as-treated and per-protocol analyses","volume":"31","author":"Olgin","year":"2020","journal-title":"J Cardiovasc Electrophysiol"},{"key":"2024073112222565000_euae189-B11","volume-title":"Safety and Efficacy of the Jewel, a Novel Patch Wearable Cardioverter Defibrillator: Results from the Jewel Investigational Device Exemption Study","author":"Hummel","year":"2023"},{"key":"2024073112222565000_euae189-B12","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1093\/biomet\/64.2.191","article-title":"Group sequential methods in the design and analysis of clinical trials","volume":"64","author":"Pocock","year":"1977","journal-title":"Biometrika"},{"key":"2024073112222565000_euae189-B13","doi-asserted-by":"crossref","first-page":"1253","DOI":"10.1016\/S0002-9149(98)00120-9","article-title":"Clinical efficacy of the wearable cardioverter-defibrillator in acutely terminating episodes of ventricular fibrillation","volume":"81","author":"Auricchio","year":"1998","journal-title":"Am J Cardiol"},{"key":"2024073112222565000_euae189-B14","doi-asserted-by":"crossref","first-page":"2016","DOI":"10.1046\/j.1460-9592.2003.00311.x","article-title":"Clinical efficacy of a wearable defibrillator in acutely terminating episodes of ventricular fibrillation using biphasic shocks","volume":"26","author":"Reek","year":"2003","journal-title":"Pacing Clin Electrophysiol"},{"key":"2024073112222565000_euae189-B15","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1111\/j.1540-8159.2004.00378.x","article-title":"Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of the WEARIT\/BIROAD","volume":"27","author":"Feldman","year":"2004","journal-title":"Pacing Clin Electrophysiol"},{"key":"2024073112222565000_euae189-B16","doi-asserted-by":"crossref","first-page":"e0281340","DOI":"10.1371\/journal.pone.0281340","article-title":"Defibrillation effectiveness and safety of the shock waveform used in a contemporary wearable cardioverter defibrillator: results from animal and human studies","volume":"18","author":"Gleva","year":"2023","journal-title":"PLoS One"},{"key":"2024073112222565000_euae189-B17","author":"Zoll"},{"key":"2024073112222565000_euae189-B18","author":"Kestra Medical Technologies Inc"},{"key":"2024073112222565000_euae189-B19","first-page":"35","article-title":"Part 5: electrical therapies: automated external defibrillators, defibrillation, cardioversion, and pacing","volume":"112","author":"American Heart Association","year":"2005","journal-title":"Circulation"},{"key":"2024073112222565000_euae189-B20","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1016\/0002-8703(89)90665-0","article-title":"Improved low energy defibrillation efficacy in man with the use of a biphasic truncated exponential waveform","volume":"117","author":"Winkle","year":"1989","journal-title":"Am Heart J"},{"key":"2024073112222565000_euae189-B21","doi-asserted-by":"crossref","first-page":"358","DOI":"10.1016\/0002-8703(89)90779-5","article-title":"Improved internal defibrillation efficacy with a biphasic waveform","volume":"117","author":"Fain","year":"1989","journal-title":"Am Heart J"},{"key":"2024073112222565000_euae189-B22","first-page":"631","article-title":"Treatment of out-of-hospital cardiac arrest with a low-energy impedance-compensating biphasic waveform automatic external defibrillator. The LIFE investigators","volume":"32","author":"Gliner","year":"1998","journal-title":"Biomed Instrum Technol"},{"key":"2024073112222565000_euae189-B23","doi-asserted-by":"crossref","first-page":"1768","DOI":"10.1161\/01.CIR.91.6.1768","article-title":"Truncated biphasic pulses for transthoracic defibrillation","volume":"91","author":"Bardy","year":"1995","journal-title":"Circulation"},{"key":"2024073112222565000_euae189-B24","doi-asserted-by":"crossref","first-page":"e004853","DOI":"10.1161\/JAHA.116.004853","article-title":"Cardioversion efficacy using pulsed biphasic or biphasic truncated exponential waveforms: a randomized clinical trial","volume":"6","author":"Schmidt","year":"2017","journal-title":"J Am Heart Assoc"},{"key":"2024073112222565000_euae189-B25","volume-title":"Summary of Safety and Effectiveness Data (SSED): LifeVest Wearable Cardioverter Defibrillator","author":"FDA","year":"2015"},{"key":"2024073112222565000_euae189-B26","doi-asserted-by":"crossref","first-page":"831","DOI":"10.1111\/jce.15417","article-title":"A wearable cardioverter defibrillator with a low false alarm rate","volume":"33","author":"Poole","year":"2022","journal-title":"J Cardiovasc Electrophysiol"}],"container-title":["Europace"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/europace\/advance-article-pdf\/doi\/10.1093\/europace\/euae189\/58536045\/euae189.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/europace\/article-pdf\/26\/7\/euae189\/58665060\/euae189.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/europace\/article-pdf\/26\/7\/euae189\/58665060\/euae189.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T02:00:10Z","timestamp":1722477610000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/europace\/article\/doi\/10.1093\/europace\/euae189\/7713315"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7]]},"references-count":26,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2024,7,2]]}},"URL":"https:\/\/doi.org\/10.1093\/europace\/euae189","relation":{},"ISSN":["1099-5129","1532-2092"],"issn-type":[{"value":"1099-5129","type":"print"},{"value":"1532-2092","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,7]]},"published":{"date-parts":[[2024,7]]},"article-number":"euae189"}}