Number of Patients
With 2 x 425 valuable, randomized patients, the trial has 90% power to claim non-inferiority and/or superiority of the S-ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications.
Duration of the Study
Patient recruitment has started in March 2011. Patient recruitment is expected to be completed Mid 2016.
At least 30 centers in the Netherlands, Germany, Denmark, the United Kingdom and the United States will participate in this trial. All centers have qualified cardiology departments with facilities for ICD implantation and have ample experience with both TV- and S-ICD implantation. Implantations are performed under routine protocols.
The Praetorian trial is registered with ClinicalTrials.gov (NCT01296022).