Stereotactic Radioablation for Ventricular Tachycardia
Conditions
Brief summary
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.
Detailed description
Study Hypotheses: 1. Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia. 2. STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest. Study Objectives: 1. Evaluate the safety of STAR in a local cohort 2. Estimate effectiveness of STAR in reducing VT burden 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.
Interventions
RADIATIONStereotactic Radioablation
External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias
Sponsors
Libin Cardiovascular Institute of Alberta
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years of age and have an implanted cardioverter defibrillator (ICD) with: 1. Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar. 2. At least one of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), and despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated): 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
* Has received prior radiotherapy to the anticipated treatment field * Pregnancy * Unable to unwilling to provide informed consent * New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite * Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia. * Active coronary ischemia in the last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of radiation treatment for VT reduction | 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment. | 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. |
| Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function. | 90 days after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality | Six months | Six month survival after treatment |
Countries
Canada
Contacts
Primary ContactVikas Kuriachan, MD
Backup ContactStephen Wilton, MD
Outcome results
None listed