Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06411392

SBRT for Ventricular Arrhythmia

Led by Medical University of Graz · Updated on 2024-05-13

10

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this study is to demonstrate the safety and efficacy of STAR (Stereotactic Antiarrhythmic Radiotherapy) in patients with VT (ventricular tachycardia) who are unresponsive to standard treatments. Additionally, the planned study aims to provide further insights into the effects of STAR on VT burden, ICD interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.

CONDITIONS

Official Title

SBRT for Ventricular Arrhythmia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Recurrent ventricular tachycardia with significant burden despite guideline-directed therapy
  • Existing protective implantable cardioverter-defibrillator (ICD) implantation unless contraindicated
  • Lack of response or intolerance to antiarrhythmic medication
  • Status post one or more catheter ablations due to monomorphic VT with early recurrence within 12 months or contraindication for endocardial ablation
  • At least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months
  • Suitable for stereotactic body radiation therapy (SBRT)
  • Age 18 years or older
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Acute myocardial infarction, percutaneous coronary intervention, or heart surgery within 3 months prior to enrollment
  • Previous intra-thoracic radiation
  • Immediate proximity to radiosensitive structures making therapy unsafe
  • Advanced symptomatic heart failure (NYHA Class IV)
  • Polymorphic VT or ventricular fibrillation confirmed by ECG or ICD
  • Extensive myocardial scar causing too large radiation volume
  • Life expectancy less than 6 months
  • Presence of a left ventricular assist device (LVAD)
  • Use of cytotoxic medications
  • Pregnancy or lactation; negative pregnancy test required for women of childbearing potential

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Graz

Graz, Austria, 8036

Actively Recruiting

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Research Team

T

Tanja Langsenlehner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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