Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Radiation: Cardiac Radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with structural heart disease and implantable cardioverter defibrillator (ICD) Age > 18 years either 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Radiosurgery<br>25 Gy in a single fraction | Radiation: Cardiac Radiosurgery<br>* Image-guided stereotactic body radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports |  | 30 days after radiosurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports |  | 12 months after radiosurgery | 
| Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks |  | At the time of inclusion and 12 months after radiosurgery | 
| Overall Survival |  | 12 months after radiosurgery | 
| Quality of Life questionnaire (EQ-5D-5L) |  | At the time of inclusion and 12 months after radiosurgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Tachycardia, Stereotactic Body Radiation Therapy, Radiosurgery