At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
In Brief
A clinical study evaluating ommitence of defibrillation testing for Ventricular Arrythmia. Completed, enrolled 965 participants across 32 sites in 4 countries.
Detailed Summary
This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.
Study Details
Timeline
Arms & Interventions
Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant
Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant
Interventions
Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted