Ventricular TachycardiaNCT06743789
Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
A study testing Radiation Therapy in people with Ventricular Tachycardia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Structural heart disease:
- Ischemic cardiomyopathy
- Non-ischemic cardiomyopathy
- Hypertrophic cardiomyopathy
- Refractory VT severity:
Show all 12Show fewer
- 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
Who cannot join
- Age < 18 years
- Pregnancy
- Prior chest radiation therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Fabiana Gregucci, M.D, 646-962-3110, fgr4002@med.cornell.edu
Fereshteh Talebi, M.D, 646-702-7830, fet4007@med.cornell.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventricular Tachycardia
- Being tested
- Radiation Therapy
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Also called Cardio Ablation
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 TherapyRadiation
Also called Cardio Ablation
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
Radiation TherapyRadiation
Also called Cardio Ablation
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
Radiation TherapyRadiation
Also called Cardio Ablation
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 TherapyRadiation
Also called Cardio Ablation
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 TherapyRadiation
Also called Cardio Ablation
Group 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
Measured: 6 months before treatment
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
Measured: 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.
Measured: 6 weeks post treatment
Secondary outcomes (17)
Number of ventricular tachycardia (VT) episodes
Measured: 3 months post
Number of ventricular tachycardia (VT) episodes
Measured: 6 months post
Number of ventricular tachycardia (VT) episodes
Measured: 12 months
Number of subacute treatment side-effects
Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
Measured: 3 months post
Number of subacute treatment side-effects
Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
Measured: 6 months post
Number of late Adverse events
Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
Measured: 1 year post
Number of late Adverse events
Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0)
Measured: 2 year post
Overall survival
Overall survival, defined as time calculated from treatment to death for any cause;
Measured: 1 year post
Overall survival
Overall survival, defined as time calculated from treatment to death for any cause;
Measured: 2 year post
Recurrence free survival
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
Measured: 3 months post
Recurrence free survival
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
Measured: 6 months post
Recurrence free survival
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
Measured: 12 months post
Recurrence free survival
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
Measured: 24 months post
Number of incidents of implantable cardiac device (ICD) shock
Measured: 3 months before treatment
Number of incidents of implantable cardiac device (ICD) shock
Measured: 3 months post treatment
Number of Anti-Arrhythmic Drugs (AADs) administration
Any reduction in Anti-Arrhythmic Drugs (AADs) administration
Measured: 3 months before treatment
Number of Anti-Arrhythmic Drugs (AADs) administration
Any reduction in Anti-Arrhythmic Drugs (AADs) administration
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start18 Dec 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Formenti, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743789
- Sponsor's protocol ID
- 23-09026474
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
- ClinicalTrials.gov ID
- NCT06743789
- Acronym / sponsor ID
- 23-09026474
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 20 Gy Radiation Dose (Arm 1 Group 1) | Experimental | Radiation: Radiation TherapyArm 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) |
| 15 Gy Radiation Dose (Arm 1 Group 2) | Experimental | Radiation: Radiation TherapyArm 1: Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day) |
| 10 Gy Radiation Dose (Arm 1 Group 3) | Experimental | Radiation: Radiation TherapyArm 1: Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day) |
| 12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1) | Experimental | Radiation: Radiation TherapyArm 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) |
| 10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2) | Experimental | Radiation: Radiation TherapyArm 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) |
| 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3) | Experimental | Radiation: Radiation TherapyArm 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Structural heart disease:
- Refractory VT severity:
- Ability to understand study protocol and to write informed consent
- Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
Key exclusion criteria (3 listed)
- Age < 18 years
- Pregnancy
- Prior chest radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyAlso: Cardio AblationGroup 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 | 20 Gy Radiation Dose (Arm 1 Group 1) |
| Radiation TherapyAlso: Cardio AblationGroup 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day) | Radiation | 15 Gy Radiation Dose (Arm 1 Group 2) |
| Radiation TherapyAlso: Cardio AblationGroup 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day) | Radiation | 10 Gy Radiation Dose (Arm 1 Group 3) |
| Radiation TherapyAlso: Cardio AblationGroup 1 (3 participants) - will receive a dose of 12 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy) | Radiation | 12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1) |
| Radiation TherapyAlso: Cardio AblationGroup 2 (3 participants) - will receive a dose of 10 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy) | Radiation | 10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2) |
| Radiation TherapyAlso: Cardio AblationGroup 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy) | Radiation | 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3) |
Primary outcome
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
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.
17 secondary outcomes
Number of ventricular tachycardia (VT) episodes
Time frame: 3 months post
Number of ventricular tachycardia (VT) episodes
Time frame: 6 months post
Number of ventricular tachycardia (VT) episodes
Time frame: 12 months
Number of subacute treatment side-effects
Time frame: 3 months post
Number of subacute treatment side-effects
Time frame: 6 months post
Number of late Adverse events
Time frame: 1 year post
Number of late Adverse events
Time frame: 2 year post
Overall survival
Time frame: 1 year post
Overall survival
Time frame: 2 year post
Recurrence free survival
Time frame: 3 months post
Recurrence free survival
Time frame: 6 months post
Recurrence free survival
Time frame: 12 months post
Recurrence free survival
Time frame: 24 months post
Number of incidents of implantable cardiac device (ICD) shock
Time frame: 3 months before treatment
Number of incidents of implantable cardiac device (ICD) shock
Time frame: 3 months post treatment
Number of Anti-Arrhythmic Drugs (AADs) administration
Time frame: 3 months before treatment
Number of Anti-Arrhythmic Drugs (AADs) administration
Time frame: 3 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Formenti, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy in people with Ventricular Tachycardia, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabiana Gregucci, M.D. (646 962 3110, fgr4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.