Ethical considerations of prospective data collection for stereotactic arrhythmia radioablation (STAR): an overview from the STOPSTORM.eu consortium

Crico, Chiara; Blanck, Oliver; Miszczyk, Marcin; Grehn, Melanie; Mandija, Stefano; Schiappacasse, Luis; Cvek, Jakub; Jadczyk, Tomasz; Kristiansen, Steen Buus; Algara López, Manuel; Maria De Ferrari, Gaetano; Postema, Pieter G.; Fast, Martin F; Pruvot, Etienne; Verhoeff, Joost J C; Andratschke, Nicolaus; Blamek, Slawomir; Perin, Marta; De Panfilis, Ludovica

doi:10.1007/s00066-025-02480-2

Published October 29, 2025 | Version v1

Journal article Open

Ethical considerations of prospective data collection for stereotactic arrhythmia radioablation (STAR): an overview from the STOPSTORM.eu consortium

1. Legal Medicine and Bioethics, AUSL-IRCCS Reggio Emilia Hospital, Italy-Fondazione IRCCS Istituto Tumori di Milano, Milan, Italy
2. ondazione IRCCS Istituto dei Tumori di Milano, Milano, Italy
3. Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Kiel, Germany
4. Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
5. Collegium Medicum-Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland
6. Department of Radiotherapy, University Medical Center Utrecht, Utrecht, The Netherlands
7. Computational Imaging group for MR therapy and diagnostics, Division Imaging and Oncology, University Medical Center Utrecht, Utrecht, The Netherlands
8. Department of Oncology, Service of Radiation Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
9. Department of Oncology, University Hospital and Faculty of Medicine Ostrava, Ostrava, Czech Republic
10. 3rd Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
11. Faculty of Space Technologies, AGH University of Krakow, Krakow, Poland
12. Interventional Cardiac Electrophysiology Group, International Clinical Research Center, St. Anne's University Hospital in Brno, Brno, Czech Republic
13. Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, Hill End Road, Harefield, London, UK
14. School of Biomedical Engineering and Imaging Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK
15. Willem Einthoven Center for Cardiac Arrhythmia Research and Management, Leiden, The Netherlands
16. Willem Einthoven Center for Cardiac Arrhythmia Research and Management, Aarhus, Denmark
17. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
18. Department of Radiation Oncology, Hospital del Mar, Hospital del Mar Research Institute, Departament de Medicina i Ciències de la Vida, Universitat Pompeu Fabra, Barcelona, Spain
19. Division of Cardiology, Department Cardiovascular and Thoracic, Città della Salute e della Scienza, University of Turin, Turin, Italy
20. Heart Center, Department of clinical and experimental cardiology, Heart Failure & Arrhythmias, Amsterdam Cardiovascular Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands
21. Heart and Vessel Department, Service of Cardiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
22. Department of Radiotherapy, Amsterdam University Medical Centers, Amsterdam, The Netherlands
23. Department of Radiation Oncology, University Hospital of Zurich, The University of Zurich, Zurich, Switzerland
24. Department of Radiotherapy, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice, Poland
25. Department of Medical and Surgical Sciences, University of Bologna, Azienda Ospedaliero-Universitaria IRCCS Bologna, Bologna, Italy

Abstract

Background: Ventricular tachycardia (VT) is a life-threatening condition, and standard treatments are not suitable for many affected patients. Stereotactic arrhythmia radioablation (STAR) has emerged as a promising 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 multicentric patient registry. The Ethics & Regulations Working Group (ERG) provides support addressing ethical and regulatory challenges.

Methods: The ERG conducted a survey 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.

Results: Among the 28 partners, there were 13 interventional clinical trials-ongoing or concluded-across seven countries; centres without ongoing trials enrolled patients under compassionate use. Most trials were single arm, with few exceptions (a randomized 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 registry to collect data from multiple local clinical trials offers an innovative approach to overcoming logistical and financial barriers in research on rare diseases.

Conclusion: 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's integration into clinical practice while upholding ethical standards in patient care and research.

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