Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

Last updated: January 6, 2025
Sponsor: University Hospital Schleswig-Holstein
Overall Status: Completed

Phase

N/A

Condition

Heart Disease

Heart Defect

Chest Pain

Treatment

Cardiac Radiosurgery

Clinical Study ID

NCT03867747
ZKS-121-09
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with structural heart disease and implantable cardioverter defibrillator (ICD)

  • Age > 18 years

  • either

  1. Recurring symptomatic monomorphic ventricular tachycardia that requires ICDintervention (e.g. shock or anti-tachycardia stimulation). At least 3 episodeswithin the 3 months prior to inclusion or

  2. induction of symptomatic monomorphic ventricular tachycardia that requires ICDintervention (e.g. shock or anti-tachycardia stimulation). Induction triggeredby 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 limitthe 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

Exclusion Criteria:

  • ICD electrode malfunction of ICD readings outside reference range

  • Lack of evidence of a myocardial scar (Computer tomography or magnetic resonancetomography for MRI-capable ICD aggregates or electrophysiological measurement)

  • No possible induction of symptomatic monomorphic ventricular tachycardianon-persistent or persistent with delivery of ICD therapies such as antitachycardicpacing or shock

  • Contraindication to radiosurgery (e.g. precise target volume definition not possibledue to image artifacts created from a left ventricular assist device (LVAD))

  • Inability to consent or missing or withdrawn consent

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Cardiac Radiosurgery
Phase:
Study Start date:
December 02, 2019
Estimated Completion Date:
October 20, 2024

Study 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

Connect with a study center

  • University Clinic Mannheim

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Hospital of the Ludwig-Maximilians-University Munich

    Munich, Bayern 80336
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • University Medical Center Schleswig-Holstein

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • University Medical Center Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23562
    Germany

    Site Not Available

  • University Medical Center Charite Berlin

    Berlin, 10117
    Germany

    Site Not Available

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