Comparing single vs. multiple doses of radiation for treating ventricular tachycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to determine whether a single high dose of radiation therapy is as effective and safe as dividing the treatment into three smaller doses for patients suffering from refractory ventricular tachycardia (VT). The study involves randomizing participants into two groups, one receiving a single fraction of radiation and the other receiving three consecutive fractions. The goal is to achieve comparable efficacy while minimizing toxicity to surrounding healthy tissues. This approach could provide a new treatment option for patients who have not responded to conventional therapies.

Why it matters

Who can join: the full rules

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 requirements
* Expected to remain available for at least 36 months after enrollment

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Prior chest radiation therapy

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Silvia Formenti, M.D. — Weill Medical College of Cornell University
• Study coordinator: Fabiana Gregucci, M.D.
• Email: fgr4002@med.cornell.edu
• Phone: 646 962 3110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.