Arrhythmias & electrophysiologyRandomised controlled trial
Stereotactic Arrhythmia Radioablation of Recurrent Ventricular Tachycardia in Structural Heart Disease
- randomized trial
- 2 centers
- 1:1
- covariate-adaptive algorithm
- prematurely terminated
Authors' conclusion
The STAR-VT-2020 trial suggests a potential clinical benefit of repeated CA over STAR in patients with SHD, despite prior failed CA at specialized centers. Because of the small study cohort of highly selected patients and several methodological limitations, the results of the prematurely terminated trial should be considered exploratory and interpreted strictly as hypothesis generating. Larger trials with optimized design are warranted. (Stereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease; NCT04612140).
Study context
- Population
- Patients with structural heart disease and recurrent ventricular tachycardia after a failure of previous catheter ablation11 in each group, followed for 28 ± 17 months · stereotactic arrhythmia radioablation (STAR) 11 · catheter ablation (CA) 11
- Participants
- 22 patients
- Comparison
- STAR vs CA after a failure of previous CA
- STARn = 11
- CAn = 11reference
- Primary endpoint
- Ventricular tachycardia (VT) recurrence
- Follow-up
- 28 ± 17 months
Primary result
As reported in the abstract
Hazard ratio
2.5
95% CI 0.97–6.6
Secondary outcomes
| Outcome | HR (95% CI) | |
|---|---|---|
| Repeated CA for VT (secondary endpoint) · significantly higher risk with STAR | 4.0 (1.2–13.8) | |
| 0.050.21520Hazard ratio (log scale) |
Trial conduct
- Trial prematurely terminated
Safety
Death, heart transplantation, left ventricular assist device · Throughout the trial
- Patients died
- 13
- Underwent heart transplantation
- 3
- Received left ventricular assist devices
- 3
- No significant differences between the 2 groups
Original publication
Summarised from the published abstract; every number is checked against it