Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

NCT06743789 | Recruiting DMC FDA Device

• 1 other identifier: 23-09026474
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes

  6 months before treatment

• Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes

  6 weeks post treatment

• Number of treatment-related serious adverse events (SAEs)

  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.

  6 weeks post treatment

Secondary Outcomes (17)

• Number of ventricular tachycardia (VT) episodes

  3 months post

• Number of ventricular tachycardia (VT) episodes

  6 months post

• Number of ventricular tachycardia (VT) episodes

  12 months

• Number of subacute treatment side-effects

  3 months post

• Number of subacute treatment side-effects

  6 months post

Study Arms (6)

20 Gy Radiation Dose (Arm 1 Group 1)

EXPERIMENTAL

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)

Radiation: Radiation Therapy

15 Gy Radiation Dose (Arm 1 Group 2)

EXPERIMENTAL

Arm 1: Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)

Radiation: Radiation Therapy

10 Gy Radiation Dose (Arm 1 Group 3)

EXPERIMENTAL

Arm 1: Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)

Radiation: Radiation Therapy

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

EXPERIMENTAL

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)

Radiation: Radiation Therapy

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

EXPERIMENTAL

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)

Radiation: Radiation Therapy

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

EXPERIMENTAL

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)

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

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)

Also known as: Cardio Ablation

20 Gy Radiation Dose (Arm 1 Group 1)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Silvia Formenti, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Gregucci, M.D.

CONTACT

646 962 3110; fgr4002@med.cornell.edu

Fereshteh Talebi, M.D.

CONTACT

646 702 7830; fet4007@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: If participants are randomized to either Arm 1 or Arm 2, participants will be in one of the three groups. Each group will enroll 3 participants, based on a criteria of consecutive enrollment over time. After 6 weeks from the last treated participant in Group 1, there will be a review of safety and efficacy of the study intervention in the treated participants before enrolling participants in the next group. This review will continue until the 3rd participant in Group 3 is enrolled and treated. Subsequently the protocol will then move into the follow up phase.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)