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St Jude Medical Initiates Cardiac Therapy Study

Posted on: Wednesday, 14 May 2008, 12:00 CDT

St Jude Medical has announced the initial enrollments into a new landmark clinical trial designed to better identify which patients could benefit from implantable cardioverter defibrillator therapy for the prevention of sudden cardiac arrest.

The Determine study, coordinated by researchers at Northwestern University and sponsored by St Jude Medical, is the first study to look at patients who already have had a heart attack (myocardial infarction), but whose hearts are less damaged, to determine if implantable cardioverter defibrillator (ICD) therapy will prolong their lives. The study is being conducted under a FDA approved investigational device exemption.

The Determine trial, a prospective, randomized, multi-center study, will study patients who have had a heart attack but have not yet had a sudden cardiac arrest, in an effort to identify patients at highest risk. The first 1,550 patients to meet inclusion criteria will be randomly selected to receive ICD therapy in combination with optimal pharmacological (drug) therapy, or randomly selected to receive optimal pharmacological therapy alone. Enrollment is expected to be completed in 36 months, with follow-up to occur for another 24 months.

In addition to the two-arm randomized Determine trial, the study will include a registry of non-randomized patients, which is expected to ultimately produce the largest database ever of clinical diagnostic cardiac MRI evaluations of post-heart attack patients, as well as provide information on how infarct mass compares to ejection fraction in identifying patients at risk of sudden cardiac arrest.

Source: Datamonitor

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