Arrhythmias & electrophysiology

Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial

CirculationPublished Randomised controlled trial

Primary result · Failed first shock for spontaneous ventricular arrhythmiaResult — go to the resultAbsolute difference −0.6% 95% CI −2.6 to 1.4

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
Methodological detailsnon-inferiority, multinational, 37 centres
  • Non-inferiority
  • Multinational
  • 37 centres

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

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