Table 3 Secondary outcome measures. QOL = quality of life
Efficacy | 6-month survival free from electrical storm and incessant VT (binary endpoint) including an initial blanking period of 8 weeks |
|---|---|
Efficacy parameters will be assessed after an initial blanking period of 8 weeks, by comparing the 6 months prior to STAR with the 6 months after treatment, including the 8-week blanking period. All arrhythmic episodes occurring during the blanking period will be collected | |
Sustained VT/VF burden as measured by number of post-treatment VT/VF episodes (ECG, ICD readouts). The main analysis will be performed by comparing the 6 months prior to STAR with the 6 months after treatment, which will include an 8-week blanking period | |
Time to first sustained VT/VF recurrence as provided by ICD readouts, sustained VT/ICD shock and/or first VT storm | |
Reduction of electrical storms and appropriate ATP and ICD shocks | |
Need for antiarrhythmic drug use: type and dosages will be collected, and a drug index will be calculated | |
Safety | Overall survival and need for heart transplant or mechanical circulatory support: reported survival and heart transplant rates during follow-up |
Incidence of cardiac arrhythmic mortality or cardiac non arrhythmic mortality | |
Non-radiation associated safety, e.g.: Hospitalization for acute heart failure necessitating inotropic therapy and if needed mechanical circulatory support except when other reason is apparent (e.g. acute coronary syndrome) ○ Cardiac tamponade ○ Major stroke or systemic embolism according to current diagnostic standards ○ ICD malfunction necessitating an interventional or operative approach | |
Physician-reported and patient-reported QoL | EQ5D, SF-35, QLQ-5, Treatment decision regret score |
Procedural technique outcome measures | Error quantification of target definition and transfer from electrophysiology mapping to CT |
Correlation between dose to the target and VT number reduction | |
Correlation between dose distribution to the target volume and scar formation | |
Dose-volume constraints for OARs: as determined by organ-specific reported toxicity (CTCAE v5) | |
The added value of additional imaging compared to standard CT imaging |