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Stereotactic arrhythmia radioablation (STAR) has emerged as a\u00a0promising experimental last-resort treatment for patients with refractory VT, but it lacks clinical standardization. To address this issue, the STOPSTORM.eu consortium aims to collect data on patients treated with STAR via the development of a\u00a0multicentric patient registry. The Ethics &amp; Regulations Working Group (ERG) provides support addressing ethical and regulatory challenges.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The ERG conducted a\u00a0survey to assess how prospective data on STAR are collected at the partner centres and to explore potential ethical concerns. Responses were analysed to evaluate clinical trial approval processes, adherence to STOPSTORM guidelines, and emerging ethical issues.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among the 28\u00a0partners, there were 13\u00a0interventional clinical trials\u2014ongoing or concluded\u2014across seven countries; centres without ongoing trials enrolled patients under compassionate use. Most trials were single arm, with few exceptions (a\u00a0randomized trial and dose escalation studies). Most ethics committees approved STAR trials without major objections, but regulatory inconsistencies were observed, resulting in approval denial or delay. Ethical concerns included potential therapeutic misconception among patients, autonomy issues due to the vulnerability of VT patients, and inequities in access to STAR. The heterogeneity in trial designs, endpoints, and follow-up strategies among participating centres posed challenges for data standardization, but using a\u00a0registry to collect data from multiple local clinical trials offers an innovative approach to overcoming logistical and financial barriers in research on rare diseases.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Multicentric non-pharmaceutical trials on STAR may present ethical, regulatory, and organizational challenges. The open registry model facilitates large-scale data collection and supports future protocol standardization. However, greater intercentre collaboration and regulatory harmonization are needed to optimize STAR\u2019s integration into clinical practice while upholding ethical standards in patient care and research.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00066-025-02480-2","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T14:59:54Z","timestamp":1761749994000},"page":"734-743","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Ethical considerations of prospective data collection for stereotactic arrhythmia radioablation (STAR): an overview from the STOPSTORM.eu consortium"],"prefix":"10.1007","volume":"202","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9742-515X","authenticated-orcid":false,"given":"Chiara","family":"Crico","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1391-1308","authenticated-orcid":false,"given":"Oliver","family":"Blanck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4375-0827","authenticated-orcid":false,"given":"Marcin","family":"Miszczyk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6170-5122","authenticated-orcid":false,"given":"Melanie","family":"Grehn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4612-5509","authenticated-orcid":false,"given":"Stefano","family":"Mandija","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7621-1662","authenticated-orcid":false,"given":"Luis","family":"Schiappacasse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1579-1792","authenticated-orcid":false,"given":"Jakub","family":"Cvek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7955-9100","authenticated-orcid":false,"given":"Tomasz","family":"Jadczyk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5565-0914","authenticated-orcid":false,"given":"Steen Buus","family":"Kristiansen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0500-9202","authenticated-orcid":false,"given":"Manuel Algara","family":"L\u00f3pez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4940-0876","authenticated-orcid":false,"given":"Gaetano Maria","family":"De Ferrari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2863-9159","authenticated-orcid":false,"given":"Pieter G","family":"Postema","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9107-4627","authenticated-orcid":false,"given":"Martin F","family":"Fast","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1386-9285","authenticated-orcid":false,"given":"Etienne","family":"Pruvot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9673-0793","authenticated-orcid":false,"given":"Joost J C","family":"Verhoeff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3647-5916","authenticated-orcid":false,"given":"Nicolaus","family":"Andratschke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0585-9100","authenticated-orcid":false,"given":"Slawomir","family":"Blamek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4631-7380","authenticated-orcid":false,"given":"Marta","family":"Perin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5509-7626","authenticated-orcid":false,"given":"Ludovica","family":"De Panfilis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,10,29]]},"reference":[{"key":"2480_CR1","unstructured":"Foth C, Gangwani MK, Ahmed I, et\u00a0al. 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M.\u00a0Miszczyk, S.\u00a0Mandija, L.\u00a0Schiappacasse, J.\u00a0Cvek, T.\u00a0Jadczyk, S.B.\u00a0Kristiansen, G.M.\u00a0De Ferrari, P.G.\u00a0Postema, M.F.\u00a0Fast, E.\u00a0Pruvot, N.\u00a0Andratschke, M.\u00a0Perin, and L.\u00a0De Panfilis and they declare that they have no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Since this research study did not involve patients, it did not require approval by an ethics committee.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical standards"}}]}}