Stereotactic Radioablation for Ventricular Tachycardia Clinical Trial
— STAR VTMOfficial title:
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia Management
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | December 30, 2024 |
| Est. primary completion date | December 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Calgary | Calgary | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Calgary | Libin Cardiovascular Institute of Alberta |
Canada,
Cuculich PS, Robinson CG. Noninvasive Ablation of Ventricular Tachycardia. N Engl J Med. 2018 Apr 26;378(17):1651-1652. doi: 10.1056/NEJMc1802625. — View Citation
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: — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |
| Primary | 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 | |
| Secondary | Overall mortality | Six month survival after treatment | Six months |