ELA Medical, a Sorin Group company, has announced the first US enrollment in the Option study (Optimal Anti-tachycardia Therapy in ICD Patients without Pacing Indications) by Dan Dan, MD, electrophysiologist and co-director of Cardiovascular Research of the Fuqua Heart Center at Piedmont Hospital, Atlanta, Georgia, USA.
Option is a global, multi-centre, prospective, single blinded, two-arm randomised trial. It evaluates ICDs with dual-chamber pacing and arrhythmia detection, with therapy enabled for slow ventricular tachyarrhythmias, compared to ICDs with single-chamber pacing and tachyarrhythmia detection, with therapy disabled for slow ventricular tachyarrhythmias.Sorin Group's Ovatio DR 6550 ICD has the most specific arrhythmia detection algorithms available, PARAD & PARAD+ (P and R Based Arrhythmia Detection). It also has Sorin Group's pacing algorithm to minimise ventricular pacing, AAIsafeR. Additionally, it has a slow ventricular tachycardia zone, BTO (Brady-Tachy Overlap) that is designed to ‘Unlock Pacing and Detection’ allowing bradycardia pacing in the slow-VT zone. “I am pleased to be an investigator in the Option Study. There is a need to continue to develop, evaluate, and utilise effective therapies and advanced algorithms in optimising treatment and managing ICD patients. The Option study assesses these advanced features and outcomes. More data are needed for understanding the incidence and long term effects of untreated slow VT in the general ICD population.” commented Dr Dan. Ovatio DR's Brady-Tachy Overlap (BTO) feature offers flexible programming for detection and treatment of slow VT while also providing bradycardia pacing support when needed. The incidence of slow VT, and the incidence of access to the health care system due to slow VT, will be reported during this study. The Option Study will enroll 450 patients in the USA, Europe, and Asia. Some 150 patients have already been enrolled in the study. Dick Ames, senior vice president, Sorin Group US Cardiac Rhythm Management, commented, “This is the first prospective study to address the surprising outcome of the David trial by testing dual chamber pacing with a minimal ventricular pacing algorithm, AAIsafeR, in the ICD population. The Option Study is another example of Sorin Group's commitment to innovative technologies to provide clinical benefits and optimal therapies to patients.”
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