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| Name | Class |
|---|---|
| Libin Cardiovascular Institute of Alberta | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radioablation Treatment | Experimental | Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radioablation | Radiation | External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 90 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality | Six month survival after treatment | Six months |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikas Kuriachan, MD | Contact | 4039443282 | vpkuriac@ucalgary.ca | |
| Stephen Wilton, MD | Contact | 4032107102 | sbwilton@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Vikas Kuriachan, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29236642 | Result | Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773. | |
| 29694814 | Result | Cuculich PS, Robinson CG. Noninvasive Ablation of Ventricular Tachycardia. N Engl J Med. 2018 Apr 26;378(17):1651-1652. doi: 10.1056/NEJMc1802625. No abstract available. |
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The data will be anonymous. Given the small number of patients in the study individual treatments and outcomes maybe looked at.
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Adult patients with a cardiomyopathy and ventricular tachycardia who have failed conventional anti-arrhythmic management.
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