Stereotactic radiotherapy for treating ventricular arrhythmia

Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)

This study is testing a new type of radiation treatment to see if it can help people with ventricular tachycardia who haven't found relief from regular treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of Graz (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Graz)
• Trial ID: NCT06411392 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with recurrent ventricular tachycardia who have not responded to conventional therapies and have an existing ICD.

Not a fit: Patients who have recently experienced acute myocardial infarction or heart surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a novel treatment option for patients with refractory ventricular tachycardia, potentially reducing their arrhythmia burden and improving quality of life.

How similar studies have performed: While the use of stereotactic radiotherapy for arrhythmias is a novel approach, similar studies have shown promise in other areas of cardiac treatment, indicating potential for success.

Eligibility criteria

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 this trial is running

Graz

• Medical University of Graz — Graz, Austria (Recruiting)

Study contacts

• Study coordinator: Tanja Langsenlehner, MD

Conditions Ventricular Arrythmia; stereotactic radiotherapy