Biotronik to assess necessity of intraoperative testing of its ICDs
This article was originally published in Clinica
Executive Summary
Biotronik has started a trial to evaluate the best method of testing its Lumax 540/340 implantable cardioverter defibrillators (ICDs). The international, prospective, randomised, controlled NORDIC ICD clinical trial will evaluate whether ICD implantation without an intraoperative defibrillation (IDF) test is as good as ICD implantation with IDF testing, regarding long-term treatment of spontaneous ventricular tachyarrhythmia. IDF testing, which involves one or two manual shocks to test the reliability of the device and set the defibrillation threshold, is thought to be necessary to ensure correct functioning of the ICD and leads, but it is associated with infrequent, serious adverse events such as death and stroke. The 580 patients in the study will be continuously followed using Biotronik Home Monitoring, which the Berlin, Germany firm says is the only CE marked and FDA-approved remote patient management system.