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

Media type: E-Article
Title: Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)
Contributor: Blanck, Oliver; Buergy, Daniel; Vens, Maren; Eidinger, Lina; Zaman, Adrian; Krug, David; Rudic, Boris; Boda-Heggemann, Judit; Giordano, Frank A.; Boldt, Leif-Hendrik; Mehrhof, Felix; Budach, Volker; Schweikard, Achim; Olbrich, Denise; König, Inke R.; Siebert, Frank-Andre; Vonthein, Reinhard; Dunst, Jürgen; Bonnemeier, Hendrik
imprint: Springer Science and Business Media LLC, 2020
Published in: Clinical Research in Cardiology
Language: English
DOI: 10.1007/s00392-020-01650-9
ISSN: 1861-0684; 1861-0692
Origination:
Footnote:
Description: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods/design</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration number</jats:title> <jats:p>NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.</jats:p> </jats:sec><jats:sec> <jats:title>Graphic abstract</jats:title> </jats:sec>

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