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Radiation Therapy

Ablative Radiation for Ventricular Tachycardia (StAR-VT Trial)

Phase 2

Waitlist Available

Led By Martin L Bernier, MD

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ishemic or non-ischemic cardiomyopathy

18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 3 years, and 5 years following study intervention

Awards & highlights

StAR-VT Trial Summary

This trial will test a new treatment for ventricular tachycardia that uses ablative radiation. The goal is to minimize possible adverse events and radiation dose to surrounding healthy tissue while maintaining a clinical benefit.

Who is the study for?

This trial is for adults with heart muscle disease who've had a special heart study and treatment but still experience rapid, irregular heartbeats. It's not for those who've had radiation in the same area before, have certain lung conditions, are pregnant or breastfeeding, or plan to become pregnant.Check my eligibility

What is being tested?

The StAR-VT trial tests a new way to treat severe irregular heartbeats using targeted body radiotherapy (20 Gy in one session). The goal is to see if this can reduce heartbeat issues with fewer side effects by lowering the dose from previous studies.See study design

What are the potential side effects?

Potential side effects may include damage to nearby healthy tissue due to radiation exposure. Specific risks will depend on individual patient factors and the precise targeting of therapy.

StAR-VT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a heart condition that affects how my heart muscle functions.

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I am 18 years old or older.

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I have had a heart rhythm study and treatment.

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I have recurring heart rhythm problems not fixed by medication.

StAR-VT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year, 3 years, and 5 years following study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year, 3 years, and 5 years following study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 3 years, and 5 years following study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute radiation toxicity within the first 90 days measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Change in arrhythmia burden measured by the number of ICD events

Change in arrhythmia burden measured by the number of VT events

Secondary outcome measures

Changes in number and doses of antiarrhythmic drugs

Late radiation toxicity occurring after the first 90 days until 5 years measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Patient-Reported Quality of life as measured by the Arrhythmia-specific questionnaire in Tachycardia and arrhythmia (ASTA)

+1 more

Other outcome measures

Overall Survival

StAR-VT Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation: 20 Gy in 1 fractionExperimental Treatment1 Intervention

External beam, stereotactic body radiotherapy of 20 Gy delivered in 1 fraction to the planning target volume (PTV) of the arrhythmogenic substrate

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

442 Previous Clinical Trials

159,165 Total Patients Enrolled

Martin L Bernier, MDPrincipal InvestigatorMUHC division of cardiology

Joanne Alfieri, MDPrincipal InvestigatorMUHC division of radiation oncology/RIMUHC

Media Library

Stereotactic Body Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05258422 — Phase 2

Ventricular Tachycardia Clinical Trial 2023: Stereotactic Body Radiotherapy Highlights & Side Effects. Trial Name: NCT05258422 — Phase 2

Stereotactic Body Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05258422 — Phase 2

$Ventricular Tachycardia Research Study Groups: Radiation: 20 Gy in 1 fraction$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has stereotactic body radiotherapy, 20 Gy in 1 fraction earned FDA authorization?

"There is some evidence for the safety of stereotactic body radiotherapy, 20 Gy in 1 fraction, leading it to receive a score of 2. No data currently supports its efficacy as this is only Phase 2."

Answered by AI

What objectives is this scientific experiment hoping to accomplish?

"The primary endpoint of this clinical evaluation, examined within a 90-day period after the study intervention, is an alteration in arrhythmia burden as recorded by ICD events. Secondary goals include long-term radiation toxicity determined through Common Terminology Criteria for Adverse Events (CTCAE) version 5.0; Severe adverse reactions classified under CTCAE v5.0 occurring after the initial 90 days post treatment; patient reported quality of life as captured via short form-36 questionnaire and Arrhythmia specific questionnaire in Tachycardia and arrhythmia (ASTA)."

Answered by AI

Is the enrollment period for this trial still open?

"The data available on clinicaltrials.gov suggests that the trial, initially posted June 1st 2022 and last updated same day, is no longer recruiting participants. However, there are 207 alternative trials presently welcoming patients to take part in their research."

Answered by AI

Recent research and studies

Circulation: Arrhythmia and ElectrophysiologyJournal

Unusual Incessant Ventricular Tachycardia

Shenthar, Jayaprakash. 2015. “Unusual Incessant Ventricular Tachycardia”. Circulation: Arrhythmia and Electrophysiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circep.115.002886.

Journal of the American College of CardiologyJournal

Prevention, Diagnosis, and Management of Radiation-associated Cardiac Disease

Desai, Milind Y., Stephan Windecker, Patrizio Lancellotti, Jeroen J. Bax, Brian P. Griffin, Oren Cahlon, and Douglas R. Johnston. 2019. “Prevention, Diagnosis, and Management of Radiation-associated Cardiac Disease”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2019.07.006.

Heart RhythmJournal

Noninvasive Stereotactic Radiosurgery (cyberheart) for Creation of Ablation Lesions in the Atrium

Sharma, Arjun, Douglas Wong, Georg Weidlich, Thomas Fogarty, Alice Jack, Thilaka Sumanaweera, and Patrick Maguire. 2010. “Noninvasive Stereotactic Radiosurgery (cyberheart) for Creation of Ablation Lesions in the Atrium”. Heart Rhythm. Elsevier BV. doi:10.1016/j.hrthm.2010.02.010.

New England Journal of MedicineJournal