Stereotactic radiotherapy for treating ventricular arrhythmia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of Stereotactic Antiarrhythmic Radiotherapy (STAR) in patients suffering from ventricular tachycardia (VT) who have not responded to standard treatments. The research will focus on the impact of STAR on the frequency of VT episodes, the need for interventions from implantable cardioverter-defibrillators (ICDs), and potential late toxicities, particularly concerning heart health. By utilizing advanced radiotherapy techniques, the study seeks to provide new insights into managing this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Recurrent VTs/VES with significant burden despite guideline-directed therapy
* Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications
* AND lack of response or intolerance to antiarrhythmic medication
* AND status post ≥1 catheter ablation due to monomorphic VT(s) and VT early recurrence (\<12 months after the last catheter ablation) OR contraindication for endocardial ablation (mechanical valve prosthesis, LV (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate)
* MINIMAL VT BURDEN: The patient must have had at least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months prior to study enrollment.
* Presence of suitability for radiation therapy with respect to SBRT
* Age ≥ 18 years
* Existing informed consent

Exclusion Criteria:

* Acute myocardial infarction or percutaneous coronary intervention or heart surgery (\<3 months before study enrollment)
* Status post intra-thoracic pre-radiation
* Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer
* Advanced symptomatic heart failure (NYHA Class IV)
* Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation)
* Extensive myocardial scar substrate that would result in too large of a radiation volume
* Life expectancy \< 6 months considering all comorbidities and in the Seattle Heart Failure Model
* Presence of a Left Ventricular Assist Device (LVAD)
* Use of cytotoxic medications
* Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential

Where it's running

• Medical University of Graz
  Graz, Austria Recruiting

Study contacts

• Study coordinator: Tanja Langsenlehner, MD
• Email: tanja.langsenlehner@medunigraz.at
• Phone: 004331638587869

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.