Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia (StAR-VT)

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Feb 16, 2022

Keywords

ClinConnect Summary

This trial, called StAR-VT, is testing a new, noninvasive treatment for ventricular tachycardia (VT), a dangerous heart rhythm problem. It uses a precise, single-session radiation therapy (SBRT) to target the scar areas in the heart that cause VT. The goal is to see if a lower dose (20 Gy in 1 fraction) is not worse than the standard historical dose (25 Gy in 1 fraction) at reducing VT episodes.

Who may be eligible: adults 18+ with cardiomyopathy (ischemic or non-ischemic) who have recurrent, monomorphic VT despite at least one antiarrhythmic drug and have had prior electrophysiology studies/ablation. People with certain conditions (like active pregnancy, prior radiation in the treatment area, or certain connective tissue diseases) may not qualify. If invited to participate, you would undergo a one-time SBRT procedure to the VT-related heart area, followed by check-ins and tests over the next 6 months to 5 years. Outcomes include changes in VT and ICD events, any acute or late radiation side effects, changes in antiarrhythmic drug use, and quality of life, along with overall survival. The study is conducted at a single center in Montreal, with oversight from a data safety committee, and results will be shared on request after the data are available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age
• • Ishemic or non-ischemic cardiomyopathy
• • Recurrent episodes of monomorphic ventricular tachycardia having failed standard treatment with at least 1 antiarrhythmic drug
• • Previous endocardial and/or epicardial electrophysiology study and ablation.
• • Participants who have a contraindication to electrophysiology studies (ventricular thrombus, absence of vascular access, valvular heart disease or mechanical heart valve that precludes left-ventricular access) may be eligible for the protocol provided the arrhythmic substrate can be defined through non-invasive methods.
• Exclusion Criteria:
• • Previous RT in the treatment field that precludes furth RT
• • Active connective tissue disease
• • Interstitial pulmonary fibrosis
• • Pregnant or breastfeeding individuals
• • Participants who plan to become pregnant or breast feed during the study duration