News | December 03, 2007

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

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.

For more information: www.sorin.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init