NCT01282918

NORDIC ICD (Cardioverter Defibrillator Implantation) Trial

NO Regular Defibrillation Testing In Cardioverter Defibrillator Implantation (NORDIC ICD) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,077 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Ventricular Tachyarrhythmia

Interventions

Type	Name	Description
DEVICE	ICD implantation w/o DF test	ICD implantation without Defibrillation Test
DEVICE	ICD implantation with DF test	ICD implantation with DF test according to standardized procedure

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2011-01-25
• Last updated: 2015-06-23

Locations

2 sites across 2 countries: Germany, Sweden