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

January 22, 2026 updated by: Weill Medical College of Cornell University

Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that arises from areas of diseased tissue in the heart. Treatment of VT can involve anti-arrhythmic drugs and catheter-based ablations. Unfortunately, despite multiple antiarrhythmic drugs, as well as the catheter-based ablation procedures, VT continues to persist in your case. At this point in time, The investigators believe that stereotactic body radiotherapy (SBRT) remains the only possible option to potentially treat VT. The investigators hypothesize that by administering SBRT at different dose levels and fractionation may achieve a better therapeutic ratio, defined as comparable efficacy with less risk of toxicity due to lower dose exposure to the normal tissue, including the heart vasculature, in patients when compared to VT patients who receive a dose of 25Gy in a single fraction which is the current treatment option.

This is a randomized dose de-escalation trial where the patients will be randomized in in one of the two experimental arms, receiving 1 single fraction OR 3 daily consecutive fractions of RT, and will be treated into a prespecified dose level group, based on the study development. The study includes three de-escalated consecutive dose level groups for each of two randomized treatment arms and there will be 3 patients per group and each group will receive a particular radiation treatment either as single treatments or three treatments.

The purpose of this treatment is to safely reduce episodes of VT.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Principal Investigator:
          • Silvia Formenti, M.D.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
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)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
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)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
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)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
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)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
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)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
Radiation: Radiation Therapy
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation
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)
Other Names:
  • Cardio Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
6 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ventricular tachycardia (VT) episodes
Time Frame: 3 months post
3 months post
Number of ventricular tachycardia (VT) episodes
Time Frame: 6 months post
6 months post
Number of ventricular tachycardia (VT) episodes
Time Frame: 12 months
12 months
Number of subacute treatment side-effects
Time Frame: 3 months post
Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
3 months post
Number of subacute treatment side-effects
Time Frame: 6 months post
Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
6 months post
Number of late Adverse events
Time Frame: 1 year post
Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
1 year post
Number of late Adverse events
Time Frame: 2 year post
Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
2 year post
Overall survival
Time Frame: 1 year post
Overall survival, defined as time calculated from treatment to death for any cause;
1 year post
Overall survival
Time Frame: 2 year post
Overall survival, defined as time calculated from treatment to death for any cause;
2 year post
Recurrence free survival
Time Frame: 3 months post
Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours
3 months post
Recurrence free survival
Time Frame: 6 months post
Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours
6 months post
Recurrence free survival
Time Frame: 12 months post
Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours
12 months post
Recurrence free survival
Time Frame: 24 months post
Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours
24 months post
Number of incidents of implantable cardiac device (ICD) shock
Time Frame: 3 months before treatment
3 months before treatment
Number of incidents of implantable cardiac device (ICD) shock
Time Frame: 3 months post treatment
3 months post treatment
Number of Anti-Arrhythmic Drugs (AADs) administration
Time Frame: 3 months before treatment
Any reduction in Anti-Arrhythmic Drugs (AADs) administration
3 months before treatment
Number of Anti-Arrhythmic Drugs (AADs) administration
Time Frame: 3 months post treatment
Any reduction in Anti-Arrhythmic Drugs (AADs) administration
3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Silvia Formenti, M.D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-09026474

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventricular Tachycardia

Clinical Trials on Radiation Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe