SBRT for Ventricular Arrhythmia

Launched by MEDICAL UNIVERSITY OF GRAZ · May 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called STAR (Stereotactic Antiarrhythmic Radiotherapy) for patients with ventricular tachycardia (VT), a type of fast heartbeat that can be dangerous. The goal is to see if STAR is a safe and effective option for people who haven’t had success with standard treatments, like medications or previous procedures. Researchers want to understand how this treatment affects the frequency of VT episodes, the need for device interventions, and any long-term side effects, especially concerning heart health.

To join the trial, participants must be at least 18 years old and have had recurrent VT episodes despite trying other treatments. They should already have a device called an implantable cardioverter-defibrillator (ICD) in place and have experienced at least three VT episodes in the last three months. However, certain conditions like recent heart surgery, advanced heart failure, or pregnancy may prevent someone from participating. Those who take part can expect close monitoring throughout the study and will contribute to important research that could help improve treatment options for others in the future.

Gender

ALL

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