Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
Weill Medical College of Cornell University
Summary
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.
Description
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that arises from areas of diseased tissue in the heart. Treatment of VT can involve anti-arrhythmic drugs and catheter-based ablations. Unfortunately, despite multiple antiarrhythmic drugs, as well as the catheter-based ablation procedures, VT continues to persist in your case. At this point in time, The investigators believe that stereotactic body radiotherapy (SBRT) remains the only possible option to potentially treat VT. The investigators hypothesize that by administering SBRT at different dose levels and fractionatio…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Structural heart disease: 1. Ischemic cardiomyopathy 2. Non-ischemic cardiomyopathy 3. Hypertrophic cardiomyopathy * Refractory VT severity: 1. VT leading to ICD shock with minimum 3 episodes in any 3-month period without reversible cause; 2. Failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 AADs) AND failed ablation (CA) 3. 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 req…
Interventions
- RadiationRadiation Therapy
Group 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)
- RadiationRadiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
- RadiationRadiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
- RadiationRadiation Therapy
Group 1 (3 participants) - will receive a dose of 12 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)
- RadiationRadiation Therapy
Group 2 (3 participants) - will receive a dose of 10 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)
- RadiationRadiation Therapy
Location
- Weill Cornell MedicineNew York, New York