Biotronik has initiated patient enrolment in a trial to investigate the use of intraoperative defibrillation testing during implantable cardioverter defibrillator (ICD) implantation.
The international, multi-centre, prospective, 1:1 randomised and controlled clinical study will evaluate whether ICD implantation without an intraoperative defibrillation test is non-inferior to implantation with the test.
The study will assess the long-term treatment efficacy of all spontaneous ventricular tachyarrhythmia episodes.
The primary endpoint of the study is the average efficacy of the first ICD shock for all true ventricular tachyarrhythmias of a patient in the observational period.
The study will enroll more than 580 patients primarily in Germany, Denmark, Sweden, Finland, Norway, Latvia and the Czech Republic.
The study will use Biotronik’s Lumax 540/340 ICD families and newer generations, and the patients will be continuously monitored using Biotronik Home Monitoring.
Biotronik Home Monitoring is the only remote patient management system with FDA and CE regulatory approvals for early detection of arrhythmias.