Status:
COMPLETED
Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
Universitätsmedizin Mannheim
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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....
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 ...
Eligibility Criteria
Inclusion
- 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
- 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- Inability to consent or missing or withdrawn consent
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03867747
Start Date
December 2 2019
End Date
October 20 2024
Last Update
January 8 2025
Active Locations (6)
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1
University Clinic Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
2
Hospital of the Ludwig-Maximilians-University Munich
Munich, Bavaria, Germany, 80336
3
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
4
University Medical Center Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105