Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

Oliver Blanck; Daniel Buergy; Maren Vens; Lina Eidinger; Adrian Zaman; David Krug; Boris Rudic; Judit Boda-Heggemann; Frank A. Giordano; Leif Hendrik Boldt; Felix Mehrhof; Volker Budach; Achim Schweikard; Denise Olbrich; Inke R. König; Frank Andre Siebert; Reinhard Vonthein; Jürgen Dunst; Hendrik Bonnemeier

doi:10.1007/s00392-020-01650-9

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

Oliver Blanck^*, Daniel Buergy, Maren Vens, Lina Eidinger, Adrian Zaman, David Krug, Boris Rudic, Judit Boda-Heggemann, Frank A. Giordano, Leif Hendrik Boldt, Felix Mehrhof, Volker Budach, Achim Schweikard, Denise Olbrich, Inke R. König, Frank Andre Siebert, Reinhard Vonthein, Jürgen Dunst, Hendrik Bonnemeier

^*Korrespondierende/r Autor/-in für diese Arbeit

63 Zitate (Scopus)

Abstract

BACKGROUND: Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown.

METHODS/DESIGN: In this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first 30 days after radiosurgery. Secondary endpoints are the assessment of VT burden, reduction of implantable cardioverter defibrillator (ICD) interventions [shock, anti-tachycardia pacing (ATP)], mid-term side effects and quality-of-life (QoL) in the first year after radiosurgery. The planned sample size is 20 patients with the goal of demonstrating safety and feasibility of cardiac radiosurgery in ≥ 70% of the patients. Quality assurance is provided by initial contouring and planning benchmark studies, joint multi-center treatment decisions, sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board.

DISCUSSION: RAVENTA will be the first study to provide the initial robust multi-center multi-platform prospective data on the therapeutic value of cardiac radiosurgery for ventricular tachycardia.

TRIAL REGISTRATION NUMBER: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.

Originalsprache	Englisch
Zeitschrift	Clinical Research in Cardiology
Jahrgang	109
Ausgabenummer	11
Seiten (von - bis)	1319-1332
Seitenumfang	14
ISSN	1861-0684
DOIs	https://doi.org/10.1007/s00392-020-01650-9
Publikationsstatus	Veröffentlicht - 01.11.2020

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Open Access funding provided by Projekt DEAL. We would kindly thank Prof. Volker Tronnier (Neurosurgery, L?beck), Prof. Karl-Heinz Kuck (Cardiology, Hamburg), and Prof. Thomas Brunner (Radiation Oncology, Magdeburg) for their participation in the data and safety monitoring board of the study.

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Blanck, O., Buergy, D., Vens, M., Eidinger, L., Zaman, A., Krug, D., Rudic, B., Boda-Heggemann, J., Giordano, F. A., Boldt, L. H., Mehrhof, F., Budach, V., Schweikard, A., Olbrich, D., König, I. R., Siebert, F. A., Vonthein, R., Dunst, J., & Bonnemeier, H. (2020). Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA). Clinical Research in Cardiology, 109(11), 1319-1332. https://doi.org/10.1007/s00392-020-01650-9

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title = "Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)",

abstract = "BACKGROUND: Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown.METHODS/DESIGN: In this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first 30 days after radiosurgery. Secondary endpoints are the assessment of VT burden, reduction of implantable cardioverter defibrillator (ICD) interventions [shock, anti-tachycardia pacing (ATP)], mid-term side effects and quality-of-life (QoL) in the first year after radiosurgery. The planned sample size is 20 patients with the goal of demonstrating safety and feasibility of cardiac radiosurgery in ≥ 70\% of the patients. Quality assurance is provided by initial contouring and planning benchmark studies, joint multi-center treatment decisions, sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board.DISCUSSION: RAVENTA will be the first study to provide the initial robust multi-center multi-platform prospective data on the therapeutic value of cardiac radiosurgery for ventricular tachycardia.TRIAL REGISTRATION NUMBER: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.",

author = "Oliver Blanck and Daniel Buergy and Maren Vens and Lina Eidinger and Adrian Zaman and David Krug and Boris Rudic and Judit Boda-Heggemann and Giordano, \{Frank A.\} and Boldt, \{Leif Hendrik\} and Felix Mehrhof and Volker Budach and Achim Schweikard and Denise Olbrich and K{\"o}nig, \{Inke R.\} and Siebert, \{Frank Andre\} and Reinhard Vonthein and J{\"u}rgen Dunst and Hendrik Bonnemeier",

year = "2020",

month = nov,

day = "1",

doi = "10.1007/s00392-020-01650-9",

language = "English",

volume = "109",

pages = "1319--1332",

journal = "Clinical Research in Cardiology",

issn = "1861-0684",

publisher = "Springer Science and Business Media Deutschland GmbH",

number = "11",

}

Blanck, O, Buergy, D, Vens, M, Eidinger, L, Zaman, A, Krug, D, Rudic, B, Boda-Heggemann, J, Giordano, FA, Boldt, LH, Mehrhof, F, Budach, V, Schweikard, A , Olbrich, D , König, IR, Siebert, FA, Vonthein, R, Dunst, J & Bonnemeier, H 2020, 'Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)', Clinical Research in Cardiology, Jg. 109, Nr. 11, S. 1319-1332. https://doi.org/10.1007/s00392-020-01650-9

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA). / Blanck, Oliver; Buergy, Daniel; Vens, Maren et al.
in: Clinical Research in Cardiology, Jahrgang 109, Nr. 11, 01.11.2020, S. 1319-1332.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

AU - Blanck, Oliver

AU - Buergy, Daniel

AU - Vens, Maren

AU - Eidinger, Lina

AU - Zaman, Adrian

AU - Krug, David

AU - Rudic, Boris

AU - Boda-Heggemann, Judit

AU - Giordano, Frank A.

AU - Boldt, Leif Hendrik

AU - Mehrhof, Felix

AU - Budach, Volker

AU - Schweikard, Achim

AU - Olbrich, Denise

AU - König, Inke R.

AU - Siebert, Frank Andre

AU - Vonthein, Reinhard

AU - Dunst, Jürgen

AU - Bonnemeier, Hendrik

PY - 2020/11/1

Y1 - 2020/11/1

N2 - BACKGROUND: Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown.METHODS/DESIGN: In this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first 30 days after radiosurgery. Secondary endpoints are the assessment of VT burden, reduction of implantable cardioverter defibrillator (ICD) interventions [shock, anti-tachycardia pacing (ATP)], mid-term side effects and quality-of-life (QoL) in the first year after radiosurgery. The planned sample size is 20 patients with the goal of demonstrating safety and feasibility of cardiac radiosurgery in ≥ 70% of the patients. Quality assurance is provided by initial contouring and planning benchmark studies, joint multi-center treatment decisions, sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board.DISCUSSION: RAVENTA will be the first study to provide the initial robust multi-center multi-platform prospective data on the therapeutic value of cardiac radiosurgery for ventricular tachycardia.TRIAL REGISTRATION NUMBER: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.

AB - BACKGROUND: Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown.METHODS/DESIGN: In this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first 30 days after radiosurgery. Secondary endpoints are the assessment of VT burden, reduction of implantable cardioverter defibrillator (ICD) interventions [shock, anti-tachycardia pacing (ATP)], mid-term side effects and quality-of-life (QoL) in the first year after radiosurgery. The planned sample size is 20 patients with the goal of demonstrating safety and feasibility of cardiac radiosurgery in ≥ 70% of the patients. Quality assurance is provided by initial contouring and planning benchmark studies, joint multi-center treatment decisions, sequential patient safety evaluations, interim analyses, independent monitoring, and a dedicated data and safety monitoring board.DISCUSSION: RAVENTA will be the first study to provide the initial robust multi-center multi-platform prospective data on the therapeutic value of cardiac radiosurgery for ventricular tachycardia.TRIAL REGISTRATION NUMBER: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.

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U2 - 10.1007/s00392-020-01650-9

DO - 10.1007/s00392-020-01650-9

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Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

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