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 Group’s 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 Group’s
“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”.