Actively Recruiting
Noninvasive Cardiac Radioablation for Ventricular Tachycardia
Led by John Sapp · Updated on 2026-03-18
12
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ventricular tachycardia (VT) causes over 350,000 sudden deaths annually in the US, often due to electrical disruptions in heart tissue scars. This study evaluates a new non-invasive treatment option called stereotactic body radiotherapy (SBRT) for patients with VT who have not responded to or cannot tolerate standard treatments such as implantable defibrillators, drug therapy, or catheter ablation. The goal is to explore if SBRT can reduce dangerous heart rhythm events by targeting the heart scar tissue causing VT. The study is a single-center, single-arm prospective cohort involving 12 patients who will receive SBRT after detailed imaging and mapping of their heart. Imaging techniques like 4D cardiac CT and cardiac MRI (for some patients) will be used to plan the radiation treatment precisely. The SBRT procedure is administered using a linear accelerator and lasts about 30 minutes. After treatment, patients will be followed up at intervals to monitor outcomes and heart device data for up to two years. Participants will undergo initial imaging and have their medical history and prior treatments reviewed to create a personalized radiation plan. Follow-ups occur at 6 and 12 weeks, 7.5 months, and then every 6 months to assess the treatment's success and review heart device records. Researchers will measure the number of ventricular arrhythmia events before and after treatment and monitor for any complications such as heart failure or other injuries. The study aims to provide detailed safety and effectiveness data over a follow-up period ranging from 7.5 months to two years.
CONDITIONS
Brief Title
Cohort Study - SBRT for VT Radioablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Structural heart disease diagnosed by cardiac imaging showing myocardial dysfunction or scar
- History of monomorphic ventricular tachycardia despite prior catheter ablation or contraindication to ablation
- Prior treatment with a class III antiarrhythmic drug that was contraindicated, ineffective, or not tolerated
- Documented sustained monomorphic VT terminated by medication, cardioversion, or ICD therapy, OR
- At least 3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), with at least one symptomatic, OR
- At least 5 episodes of monomorphic VT treated with ATP regardless of symptoms, OR
- At least 1 appropriate ICD shock, OR
- At least 3 monomorphic VT episodes within 24 hours
- VT events must be confirmed by ECG, monitor, or ICD download
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Prior radiotherapy to the likely treatment field
- Inotrope-dependent heart failure or expected life expectancy less than 1 year without VT
- Presenting arrhythmia is polymorphic VT or ventricular fibrillation (VF)
- Pregnancy
- Active ischemia or recent acute coronary syndrome within 30 days
- Reversible causes of VT such as drug-induced arrhythmia
- Canadian Cardiovascular Society functional class IV angina
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will be assessed based on clinical imaging data, medical history, and previous ablation data.
Duration - Up to 2 weeks
Participants undergo additional imaging including 4D cardiac CT, cardiac MRI (if safe), and planning CT to allow for treatment planning.
1 to 3 imaging visits depending on recent prior imaging and safety considerations.
Duration - Single day
Participants receive a single 30-minute Stereotactic Body Radiotherapy (SBRT) ablation procedure using a TrueBeam linear accelerator with specialized imaging guidance.
1 treatment visit (in-person, approximately 30 minutes).
Duration - At least 7.5 months up to 2 years
Participants attend scheduled follow-up visits to monitor outcomes and perform ICD interrogation as part of standard care.
Follow-up visits occur at 6 and 12 weeks, 7.5 months, then every 6 months thereafter.
Trial Site Locations
Total: 1 location
1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
Research Team
K
Karen Giddens
J
John Sapp, MD FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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