Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
Last updated on July 2021Recruitment
- 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