Sorin Group initiates European study to show superiority of dual chamber ICDs

20 November 2006 Deutsch

Paris, France. Sorin Group (MIL:SRN) Cardiac Rhythm Management (CRM) Business Unit has initiated a study to demonstrate that implantable dual chamber cardioverter defibrillators (ICDs) have greater efficacy than single chamber ICDs in reducing inappropriate shock delivery and have the same efficacy in reducing all-cause patient mortality and hospitalizations due to cardiovascular events.

Titled OPTION (optimal antitachycardia therapy in ICD patients without pacing indication), the study aims to demonstrate that patients implanted with dual chamber ICDs incorporating advanced features such as optimal dual chamber arrhythmia detection, a pacing mode that minimizes ventricular pacing and a slow ventricular tachycardia zone, have better outcomes in terms of inappropriate shock delivery, patient mortality and hospitalizations than patients with single chamber devices.

The first patients enrolled in Germany, Portugal and in Italy were all implanted with Sorin Groups OVATIO dual chamber ICDs. OVATIO ICDs feature the innovative PARAD+ arrhythmia detection algorithm, AAIsafeR mode that limits ventricular pacing and a slow ventricular tachyarrhythmia (VT) zone. All patients included in the study are randomized to either single chamber ICD therapy following standard clinical practice with an active monitoring zone ON to allow ventricular arrhythmia documentation, or to dual chamber detection and therapy in the slow VT zone (BTO) with AAIsafeR switched on.

The principal study investigator, Dr. Christof Kolb, Deutsches Herzzentrum, Munich, Germany, commented, We are confident that OPTION will significantly help us assess whether dual chamber ICD therapy gives clinical benefit to patients without a pacing indication. OVATIO DR innovative features and the design of the trial will enable us to investigate the impact of ICD therapy on the full range of ventricular tachyarrhythmias, including slow VTs, in combination with pacing backup in patients with impaired left ventricular function to avoid unnecessary ventricular stimulation. We also expect that the results of OPTION will help us in better selecting ICD candidates.

Another objective of the study is to determine how to best identify patients who could benefit from ICD therapy using Sorin Groups T-variability risk stratification method, a noninvasive Holter-based test that analyzes micro-volt variations that are linked to the development of life-threatening tachyarrhythmias.

Patient recruitment will be completed in 18 months. A follow-up phase of 27 months is scheduled after enrolment to allow monitoring of the development of AF and CHF. The OPTION study is multi-centre prospective, single blind, and two-arm randomized and will enroll 450 patients in Europe, Canada and the US. Interim results will be published every 12 months.

Andre-Michel Ballester, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit commented, The OPTION study exemplifies our commitment to provide clinically tested solutions that can bring optimal treatment and better quality of life to patients with cardiac arrhythmias.

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