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
Ischemic cardiomyopathy
Non-ischemic cardiomyopathy
Hypertrophic cardiomyopathy
Age < 18 years
Pregnancy
Prior chest radiation therapy
Parallel
Radiation Therapy
RadiationGroup 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)
Radiation Therapy
RadiationGroup 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Radiation Therapy
RadiationGroup 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Radiation Therapy
RadiationGroup 1 (3 participants) - will receive a dose of 12 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)
Radiation Therapy
RadiationGroup 2 (3 participants) - will receive a dose of 10 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)
Radiation Therapy
RadiationGroup 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)
6
Treatment groupsSee each treatment group below.
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
Number of treatment-related serious adverse events (SAEs)
Safety: SAEs rate ≤ 30% defined using Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) that could be treatment-related (possibly, probably, or definitely related to treatment) at 6 weeks after treatment is considered clinically acceptable. The SAEs are defined as any grade 3 toxicity requiring hospitalization or any grade 4 to 5 toxicity.
Number of ventricular tachycardia (VT) episodes
Number of ventricular tachycardia (VT) episodes
Number of ventricular tachycardia (VT) episodes
Number of subacute treatment side-effects
Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
Click on the lead sponsor to view all of their trials.
