Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Ventricular Tachycardia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ven...

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

Tracking Information

NCT #
NCT03867747
Collaborators
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Hendrik Bonnemeier, Prof. University Hospital Schleswig-Holstein Principal Investigator: Juergen Dunst, Prof. University Hospital Schleswig-Holstein