Biotronik has initiated the Nordic ICD clinical trial, which enrolls the implantable cardioverter defibrillator (ICD) patients, by its coordinating clinical investigator, Dietmar Bansch at the University Hospital of Rostock and Stefan Kuster an investigator at the DRK Hospital of Mölln/Ratzeburg
Nordic ICD is an international, multicenter, prospective, 1:1 randomized, controlled clinical study to evaluate whether ICD implantation without an intraoperative defibrillation (DF) test is noninferior to ICD implantation with intraoperative DF testing, regarding the long-term treatment efficacy of all spontaneous ventricular tachyarrhythmia episodes.
The primary endpoint is the average efficacy of the first ICD shock for all true ventricular tachyarrhythmias of a patient in the observational period.
Nordic ICD will be limited to the use of Biotronik’s Lumax 540/340 ICD families and newer generations, with the capability of high energy defibrillation output.
Biotronik said patients will be continuously monitored using company’s Home Monitoring to ensure maximum safety.
Biotronik Home Monitoring is the only remote patient management system with FDA and CE regulatory approvals for early detection and is therefore ideal for up-to-the minute tracking of device and lead functioning and for collecting important device-based information regarding arrhythmias and changes in a patient’s clinical condition.