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Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia (StAR-VT)

Study acronym: StAR-VT
StatusEnrolling by Invitation
PhasePhase 2
Started
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Record History

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  1. Minor 2 versions Re-verified since May 27, 2024, no change to tracked fieldsv4-v5
  2. Notable Start date changed from estimate of Jun 1, 2022 to Jul 1, 2023v3
  3. Notable Start date: Mar 1, 2022 to Jun 1, 2022
    • Study description expanded, about 1 word
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In 2017 a novel treatment approach to a series of 5 patients with refractory VT was introduced, using ablative radiation with a stereotactic body radiation therapy (SBRT) technique to arrhythmogenic scar regions defined by noninvasive cardiac mapping. More recently, Robinson et al. reported on the results of their Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia (ENCORE-VT) trial, also using a similar SBRT technique in a series of 17 patients with refractory VT. Both studies report a marked reduction in VT burden, a decrease in antiarrhythmic drug use, and an improvement in quality of life. Since then, numerous other centres have detailed their initial experience with this technique. These initial results suggest that this new treatment paradigm has the potential to improve morbidity and mortality for patients suffering from treatment-refractory VT by means of a minimally invasive technique, but requires further validation for widespread use. The appropriate dose for therapeutic effect of this new treatment is not well established as only a single dose prescription of 25 Gy in 1 fraction has been described with benefit. In this phase 2 trial, the investigators plan on expanding the experience with this technique but also by contributing to understanding the relationship between dose-effect relationship through a dose de-escalation stratification, to 20 Gy in 1 fraction, with the goal of minimizing possible adverse events and radiation dose to surrounding healthy tissue while maintaining a clinical benefit.
Trial Details
NCT Number NCT05258422
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)
Ventricular Tachycardia, Arrhythmia, Arrhythmic Storm, Radiation Toxicity
Related terms Arrhythmias, Cardiac, Radiation Injuries, Tachycardia, Ventricular
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov