NCT06743789 · Weill Medical College of Cornell University
Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
Radiation 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)
RADIATION
Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
RADIATION
Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
RADIATION
Radiation 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)
RADIATION
Radiation 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)
RADIATION
Radiation Therapy
Group 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)
Primary outcome measures
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
Time frame: 6 months before treatment
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
Time frame: 6 weeks post treatment
Number of treatment-related serious adverse events (SAEs)
Time frame: 6 weeks post treatment
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Age \< 18 years
- Prior chest radiation therapy
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2026 · Source of record for eligibility and locations