An interventional study of Stereotactic Radioablation in Stereotactic Radioablation for Ventricular Tachycardia, sponsored by University of Calgary. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.
STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.
Study Hypotheses:
Study Objectives:
Study Design: Prospective single center, single arm, non-randomized trial.
Number of patients: 20 patients
Study Duration: Enrollment will occur over three years and at least minimum follow up of six months
Study Population: Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.
Primary safety endpoint: Any treatment-related serious adverse events in the first 90 days.
Primary efficacy endpoint: Reduction in VT episodes tracked by ICD with a six week blanking period.
Statistical methodology: Wilcoxon matched-pairs signed-ranks test to compare the number of treated episodes before and after.
Assessment of events: Adjudicated by study investigators
Economic Analysis: Costs and resources required for STAR .Compare costs between the patients undergoing STAR with conventional catheter-based VT ablation.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's planned enrollment of 20 is below the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
18 years of age and have an implanted cardioverter defibrillator (ICD) with:
A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy.
B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours VT events must be confirmed by ECG/monitor or ICD download.
Exclusion Criteria:
Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia
Radiation: Stereotactic Radioablation
External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias
Efficacy of radiation treatment for VT reduction
Reduction in VT burden tracked by ICD and defined as the difference between the number of ICD-treated VT/VF episodes comparing the 6 months prior to treatment to the 6 months after treatment.
Time frame: 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment.
Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function.
Any treatment-related serious adverse events including pericarditis, radiation pneumonitis, deterioration in cardiac function, new or worsening cardiac valve dysfunction, and implantable cardioverter defibrillator malfunction.
Time frame: 90 days after treatment
Overall mortality
Six month survival after treatment
Time frame: Six months
Plan to share: No — The data will be anonymous. Given the small number of patients in the study individual treatments and outcomes maybe looked at.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Calgary