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Cohort Study - SBRT for VT Radioablation

RecruitingNAAges any - anyAllJohn Sapp
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In plain words

What the trial is, and whether it could suit you

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Current treatment for VT consists of either implantable defibrillators (ICDs), suppressive drug therapy, catheter ablation or a combination of all 3. Implantable Defibrillators (ICDs) reduce sudden death and can terminate some ventricular tachycardia (VT) without shocks, but they don't prevent VT. The occurrence of โ‰ฅ1 ICD shock is associated with reductions in mental well-being and physical functioning, and increases in anxiety and sometimes depression. Further, ICD shocks have been consistently associated with adverse outcomes, including heart failure and death. Furthermore, the most important predictor of ICD shocks is a history of prior ICD shocks. Therapies

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar, AND * 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: Documented sustained monomorphic VT terminated by pharmacologic means, DC cardioversion or manual ICD Therapy. B: โ‰ฅ3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: โ‰ฅ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: โ‰ฅ1 appropriate ICD shocks, E: โ‰ฅ3 monomorphic VT episodes within 24 hours \*\* VT events must be confirmed by ECG/monitor or ICD download. Exclusion Criteria: * Unable or unwilling to provide informed consent * Have received prior radiotherapy to the likely treatment field * Inotrope-dependent heart failure or an anticipated life-expectancy of \< 1 year in the absence of VT * Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF) * Pregnancy * Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
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What it tests

  • Stereotactic Body Radiotherapy (SBRT) ablation of VT
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Where

1 site
Nova Scotia Health Authority
Halifax, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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