Actively Recruiting

Phase Not Applicable
All Genders
NCT04162171

Cohort Study - SBRT for VT Radioablation

Led by John Sapp · Updated on 2026-03-18

12

Participants Needed

1

Research Sites

326 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Current treatment for VT consists of either implantable defibrillators (ICDs), suppressive drug therapy, catheter ablation or a combination of all 3. Implantable Defibrillators (ICDs) reduce sudden death and can terminate some ventricular tachycardia (VT) without shocks, but they don't prevent VT. The occurrence of ≥1 ICD shock is associated with reductions in mental well-being and physical functioning, and increases in anxiety and sometimes depression. Further, ICD shocks have been consistently associated with adverse outcomes, including heart failure and death. Furthermore, the most important predictor of ICD shocks is a history of prior ICD shocks. Therapies to suppress VT include antiarrhythmic drug therapy and catheter ablation, neither however is universally effective. When VT recurs despite antiarrhythmic drug therapy and catheter ablation, novel yet invasive, approaches may be required. Such invasive procedures carry consequent risks of cardiac and extra-cardiac injury. Stereotactic body radiotherapy (SBRT) is a non-invasive technique that delivers high doses of radiation precisely to specified regions in the body, while minimizing exposure to adjacent tissue. This technique is currently, and commonly used in the treatment of cancer. Conventional application of SBRT has made use of its ability to spare non-target tissue, including for treatment of tumors near the heart. More recently, clinicians have changed the paradigm, by focusing radioablative energy on ventricular scar responsible for ventricular tachycardia. Pre-clinical studies have supported the concept and were followed by first-in-human VT therapeutic experience in 2017. Subsequent studies have had encouraging results for patients who failed or were unable to tolerate conventional treatment.

CONDITIONS

Official Title

Cohort Study - SBRT for VT Radioablation

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging showing segmental myocardial dysfunction or scar
  • History of monomorphic ventricular tachycardia despite prior catheter ablation or contraindication to ablation
  • History of treatment with a class III antiarrhythmic drug that was ineffective, not tolerated, or contraindicated
  • Documented sustained monomorphic VT terminated by medication, cardioversion, or ICD therapy, or
  • Three or more episodes of monomorphic VT treated with antitachycardia pacing (ATP), with at least one symptomatic, or
  • Five or more episodes of monomorphic VT treated with ATP regardless of symptoms, or
  • One or more appropriate ICD shocks for VT, or
  • Three or more monomorphic VT episodes within 24 hours
  • VT events must be confirmed by ECG, monitor, or ICD download
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Prior radiotherapy to the treatment area
  • Inotrope-dependent heart failure or expected life expectancy under 1 year without VT
  • Presenting arrhythmia is polymorphic VT or ventricular fibrillation
  • Pregnancy
  • Active ischemia or reversible cause of VT such as drug-induced arrhythmia
  • Recent acute coronary syndrome within 30 days due to arterial thrombosis
  • Canadian Cardiovascular Society functional class IV angina

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada, B3H 3A7

Actively Recruiting

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Research Team

K

Karen Giddens

CONTACT

J

John Sapp, MD FRCPC

CONTACT

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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