Recruiting

Radioablation vs. Fractions

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06743789

Conditions

Ventricular Tachycardia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Radiation Therapy

Radiation Therapy

Radiation Therapy

Radiation Therapy

Study Details

Brief 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.

Conditions

Ventricular Tachycardia

Study ID

NCT06743789

Start date

Dec 18, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 20 Gy Radiation Dose (Arm 1 Group 1)

Arm 1:

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)

experimental: 15 Gy Radiation Dose (Arm 1 Group 2)

Arm 1:

Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)

experimental: 10 Gy Radiation Dose (Arm 1 Group 3)

Arm 1:

Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)

experimental: 12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1)

Arm 2:

Group 1 (3 participants) - will receive a dose of 12 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)

experimental: 10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2)

Arm 2:

Group 2 (3 participants) - will receive a dose of 10 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)

experimental: 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3)

Arm 2:

Group 3 (3 participants) - will receive a dose of 8 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)

Interventions

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 Therapy

Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)

Radiation Therapy

Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)

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 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 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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Fabiana Gregucci, M.D.

646 962 3110fgr4002@med.cornell.edu

Fereshteh Talebi, M.D.

646 702 7830fet4007@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Fabiana Gregucci, M.D

646-962-3110fgr4002@med.cornell.edu

Fereshteh Talebi, M.D

646-702-7830fet4007@med.cornell.edu

Principal Investigator:

Silvia Formenti, M.D.

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-01-26.