Study Compares Dual-Chamber to Single-Chamber ICD Patient Outcomes


December 4, 2007

December 4, 2007 - ELA Medical Inc. intiated U.S. enrollment in the OPTION study (Optimal Anti-tachycardia Therapy in ICD Patients without Pacing Indications), which will evaluate therapies and advanced algorithms in optimizing treatment and managing ICD patients.

The OPTION study, led by Dan Dan, M.D., electrophysiologist and co-director of Cardiovascular Research of the Fuqua Heart Center at Piedmont Hospital, Atlanta, GA, is a global, multi-center, prospective, single blinded, two-arm randomized trial. It will evaluate 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.

The study will use Sorin Group’s Ovatio DR 6550 ICD arrhythmia detection algorithms, PARAD & PARAD (P and R Based Arrhythmia Detection). It also will use Sorin Group’s pacing algorithm to minimize 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.

“There is a need to continue to develop, evaluate, and utilize effective therapies and advanced algorithms in optimizing 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 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 healthcare 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.

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