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Radiation Therapy

Ablative Radiation for Ventricular Tachycardia (StAR-VT Trial)

Phase 2

Waitlist Available

Led By Joanne Alfieri, 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

Must not have

Interstitial pulmonary fibrosis

Previous RT in the treatment field that precludes furth RT

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with interstitial pulmonary fibrosis.

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I've had radiation therapy in the same area that cannot be treated again.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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)

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Other study objectives

Overall Survival