Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

Not Applicable

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Radiation: Cardiac Radiosurgery

• Registration Number: NCT03867747
• Lead Sponsor: University Hospital Schleswig-Holstein

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

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-08
• Study Start: 2019-12-02
• Primary Completion: 2023-11-20
• Study Completion: 2024-10-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac Radiosurgery	Cardiac Radiosurgery	25 Gy in a single fraction

Primary Outcome Measures

Name	Time	Method
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports	30 days after radiosurgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

University Clinic Mannheim; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Hospital of the Ludwig-Maximilians-University Munich; 🇩🇪 Munich, Bayern, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

University Medical Center Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

University Medical Center Charite Berlin; 🇩🇪 Berlin, Germany