Comparing single vs. multiple doses of radiation for treating ventricular tachycardia
Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
NA · Weill Medical College of Cornell University · NCT06743789
This study is testing if a single high dose of radiation can effectively treat people with hard-to-treat ventricular tachycardia just as well as giving them three smaller doses.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06743789 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with structural heart disease and refractory VT who have not responded to standard treatments.
Not a fit: Patients under 18, pregnant individuals, or those who have previously received chest radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and more effective treatment option for patients with refractory ventricular tachycardia.
How similar studies have performed: While the use of radiation therapy for VT is an emerging approach, similar studies have shown promise in treating other arrhythmias, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventricular Tachycardia