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

Clin Res Cardiol. 2020 Nov;109(11):1319-1332. doi: 10.1007/s00392-020-01650-9. Epub 2020 Apr 18.


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 ( Registered March 8, 2019. The study was initiated on November 18th, 2019, and is currently recruiting patients.

Keywords: Cardiac arrhythmia; Clinical feasibility trial; Multi-center; Multi-platform; Radioablation; Radiosurgery; SBRT; Stereotactic body radiotherapy; Ventricular tachycardia.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Catheter Ablation / methods*
  • Feasibility Studies
  • Female
  • Germany
  • Humans
  • Male
  • Prospective Studies
  • Quality of Life*
  • Radiosurgery / methods*
  • Tachycardia, Ventricular / physiopathology
  • Tachycardia, Ventricular / therapy*
  • Treatment Outcome

Associated data