Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
This is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular tachycardia (VT). These patients have not exhibited positive responses to conventional medications or procedures. This study aims to explore whether an alternative approach could yield more beneficial outcomes.
• Age ≥ 18 years
• Structural heart disease:
‣ Ischemic cardiomyopathy
⁃ Non-ischemic cardiomyopathy
⁃ Hypertrophic cardiomyopathy
• Refractory VT severity:
‣ VT leading to ICD shock with minimum 3 episodes in any 3-month period without reversible cause;
⁃ Failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 AADs) AND failed ablation (CA)
⁃ OR ablation (CA) contraindicated
• Ability to understand study protocol and to write informed consent
• Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
• Expected to remain available for at least 36 months after enrollment