Ventricular Tachyarrhythmia Clinical Trial
Official title:
NO Regular Defibrillation Testing In Cardioverter Defibrillator Implantation (NORDIC ICD) Trial
The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF testing regarding the efficacy of the first ICD shock for the treatment of true spontaneous ventricular tachyarrhythmias.
The NORDIC ICD study is justified by the need to compare the clinical outcome between
patients that did receive defibrillation (DF) testing and those who did not receive DF
testing during ICD implantation. The NORDIC ICD study will evaluate the impact of
intra-operative DF testing on the long-term ICD first shock efficacy for true ventricular
tachyarrhythmias in the observational period. Therefore, the primary analysis of this study
will consider all ventricular tachyarrhythmia episodes treated by ICD shock(s) during the
trial follow-up period.
Moreover, the Home MonitoringTM system of BIOTRONIK will be used in order to monitor the
technical system integrity, device programming and cardiac performance continuously. It
supports early information about the occurrence of VT/VF (Ventricular
Tachycardia/Ventricular Fibrillation) episodes and corresponding therapies such as ICD
shocks. The Home MonitoringTM capability offered by active implants has the potential to
detect some of these trends early and thus to offer the possibility to intervene in time for
prevention of fatal worsening of cardiac performance.
1077 patients were enrolled and randomized (1:1) in 48 centers in five European countries
(Germany, Czech Republic, Denmark, Sweden and Latvia).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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