Arrhythmias & electrophysiologyRandomised controlled trial
Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial
- Randomised controlled trial
- non-inferiority
- multinational
- 37 centres
Authors' conclusion
PRAETORIAN score-guided omission of DF testing after S-ICD implantation did not increase the risk of failed first shocks for spontaneous ventricular arrhythmias and reduced procedural risk without increasing S-ICD revisions.
Study context
- Population
- Patients undergoing subcutaneous ICD (S-ICD) implantation
- Participants
- 965 patients
- Comparison
- No defibrillation (DF) testing vs DF testing at S-ICD implantation
- No-DF testingn = 483
- DF testingn = 482reference
- Primary endpoint
- Failed first shock for spontaneous ventricular arrhythmias (non-inferiority margin 3% absolute risk)
- Follow-up
- Median 41 months
Primary result
As reported in the abstract
Failed first shock for spontaneous ventricular arrhythmia · median 41 months
Absolute difference
−0.6%
95% CI −2.6 to 1.4
P < 0.001
By group
No-DF testing vs DF testing
absolute difference −0.6% (95% CI −2.6 to 1.4); P < 0.001
Non-inferiority margin 3 as printed, not drawn
Secondary outcomes
All-cause mortality
- No significant difference in all-cause mortality (HR, 0.9 [95% CI, 0.6-1.4])
Arrhythmic death
- No significant difference in arrhythmic death (HR, 0.4 [95% CI, 0.04-3.4])
Safety
- Potential DF testing-related complications
- 1.7%
Postoperative S-ICD revisions due to inadequate positioning
- Identical between groups (n=2 each)
Original publication
Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial. Circulation. Published 25 April 2026. doi:10.1161/circulationaha.126.080638
Summarised from the published abstract; every number is checked against it