Status:
UNKNOWN
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Libin Cardiovascular Institute of Alberta
Conditions:
Stereotactic Radioablation for Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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 availa...
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 ...
Eligibility Criteria
Inclusion
- 18 years of age and have an implanted cardioverter defibrillator (ICD) with:
- Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar.
- 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
- 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04065802
Start Date
April 14 2021
End Date
December 30 2024
Last Update
November 15 2022
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6