Enrollment commences in NORDIC implantable cardioverter defibrillator clinical trial

Feb 25 2011

BIOTRONIK SE & Co. KG announced today the start of the NORDIC ICD clinical trial. The first implantable cardioverter defibrillator (ICD) patients were enrolled by its coordinating clinical investigator, Prof. Dr. Dietmar Bänsch at the University Hospital of Rostock and the investigator Dr. Stefan Kuster at the DRK Hospital of Mölln/Ratzeburg.

“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.”

"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 Professor 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 optimize the clinical routine of this procedure and increase access to its life-saving therapy."

"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 Dr. Johan Brandt, PhD, MD, from Skane University Hospital in 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." Dr. Brandt developed the study protocol with Prof. Bänsch. Both will oversee and control the study activities as coordinating clinical investigators.

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. More than 580 patients will be enrolled, primarily in Germany, Denmark, Sweden, Finland, Norway, Latvia and Czech Republic.

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. 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.

Source BIOTRONIK SE & Co. KG