Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)

  • End date
    Jul 18, 2023
  • participants needed
  • sponsor
    University Hospital Schleswig-Holstein
Updated on 18 April 2022
heart disease
implantable cardioverter-defibrillators
catheter ablation
antiarrhythmic drug
premature ventricular contractions


Patients with refractory ventricular extrasystoles or tachycardia not eligible for catheter ablation will receive single fraction stereotactic body radiation therapy (cardiac radiosurgery) with 25 Gy.

Investigators initiated this study to demonstrate that in at least 70% of the patients the planned cardiac radiosurgery may be performed without any interruption or treatment related interventional events within the first 30 days after treatment.


Primary endpoint: 30-day post-intervention safety defined as presence of both, radiosurgery delivery of the planned dose to the intended target area, and no possibly treatment related serious adverse events in the first 30 days after treatment.

Secondary endpoints: evaluated at 1 year

  • Changes in ventricular tachycardia episodes and ICD shocks
  • Changes in antiarrhythmic medication due to treatment effects
  • Occurrence of possibly treatment related adverse events in the first year after treatment (according to CTCAE v5.0)
  • Changes in patient-reported quality of life (recorded as EQ-5D-5L)
  • Overall survival
  • Safety profile

Condition Ventricular Tachycardia
Treatment Cardiac Radiosurgery
Clinical Study IdentifierNCT03867747
SponsorUniversity Hospital Schleswig-Holstein
Last Modified on18 April 2022


Yes No Not Sure

Inclusion Criteria

Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
Age > 18 years
Recurring symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). At least 3 episodes within the 3 months prior to inclusion or
induction of symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). Induction triggered by ICD or during electrophysiology studies (EPS) or both, a) and b)
Refractory to antiarrhythmic combination therapy
Beside the cardiac conditions: No competing illness that would additionally limit the life expectancy to less than 6 months
No prior radiation therapy in the thorax area
No pregnancy and no active breastfeeding
Ability to consent and consent to study participation

Exclusion Criteria

ICD electrode malfunction of ICD readings outside reference range
Lack of evidence of a myocardial scar (Computer tomography or magnetic resonance tomography for MRI-capable ICD aggregates or electrophysiological measurement)
No possible induction of symptomatic monomorphic ventricular tachycardia non-persistent or persistent with delivery of ICD therapies such as antitachycardic pacing or shock
Contraindication to radiosurgery (e.g. precise target volume definition not possible due to image artifacts created from a left ventricular assist device [LVAD])
Inability to consent or missing or withdrawn consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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