Ventricular Tachycardia
Conditions
Keywords
Ventricular Tachycardia, Stereotactic Body Radiation Therapy, Radiosurgery
Brief summary
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
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 * Changes in patient-reported quality of life * Overall survival * Safety profile
Interventions
RADIATIONCardiac Radiosurgery
Image-guided stereotactic body radiation therapy
Sponsors
Universitätsmedizin Mannheim
University Hospital Schleswig-Holstein
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with structural heart disease and implantable cardioverter defibrillator (ICD) * Age \> 18 years * either 1. 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 2. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports | 30 days after radiosurgery |
Secondary
| Measure | 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 | At the time of inclusion and 12 months after radiosurgery |
Countries
Germany
Outcome results
None listed