Biotronik announced the start of the NORDIC ICD clinical trial. NORDIC ICD is an international, multicentre, prospective, 1:1 randomised, controlled clinical study to evaluate whether implantable cardioverter defibrillator (ICD) implantation without an intraoperative defibrillation test is noninferior to ICD implantation with intraoperative defibrillation testing, regarding the long-term treatment efficacy of all spontaneous ventricular tachyarrhythmia episodes.
The first implantable cardioverter defibrillator (ICD) patients were enrolled by its coordinating clinical investigator Dietmar Bänsch at the University Hospital of Rostock and the investigator Stefan Kuster at the DRK Hospital of Mölln, Ratzeburg, Germany.
“Intraoperative defibrillation testing is the primary aspect of routine ICD implantation that makes it different from pacemaker implantation, and it is a practice that began during the early days of therapy development when the technology was not as advanced as it is today,” explained Bänsch. “The practice has evolved somewhat, from extensive threshold testing down to the one or two manual shocks that are common today. Nevertheless, given the latest advances in ICD development, the major question remains as to whether we can optimise the clinical routine of this procedure and increase access to its life-saving therapy.”
The primary endpoint of the trial is the average efficacy of the first ICD shock for all true ventricular tachyarrhythmias of a patient in the observational period. More than 580 patients will be enrolled, primarily in Germany, Denmark, Sweden, Finland, Norway, Latvia and Czech Republic.
“While it is has been commonly thought that intraoperative defibrillation testing is necessary to ensure adequate ICD and lead function it is also associated with infrequent, however serious adverse events such as death and stroke,” commented Johan Brandt, Skane University Hospital, Sweden. “Even though there is minimal data supporting routine intraoperative defibrillation testing, and no international guidelines that substantiate this practice, a clinical routine established decades ago is difficult to change. Trials such as NORDIC ICD are necessary to develop a solid evidence base that may alter clinical practice.” Brandt developed the study protocol with Bänsch. Both will oversee and control the study activities as coordinating clinical investigators.
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. Patients will be continuously monitored using Biotronik Home Monitoring to ensure maximum safety. This 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.