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The company said that the CRYSTAL AF (Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke) trial has taken its first enrolments and the trial will use the Reveal XT Insertable Cardiac Monitor (ICM), which provides up to three years of continuous heart rhythm monitoring, to assess the incidence of atrial fibrillation (AF) in patients with cryptogenic stroke (stroke of an undetermined cause) or transient ischemic attack (TIA). About 450 cryptogenic stroke or TIA patients will be involved in the study at 45 centres in Europe, Canada and the US.
A further trial, SISTERS (Spasticity In Stroke -- Randomized Study), will compare the effectiveness of Intrathecal Baclofen (ITB) Therapy to best medical therapy in managing generalised, severe, post-stroke spasticity (tightening of the muscles). Approximately 88 patients will take part in this study, designed to supplement clinical evidence for the FDA-approved ITB Therapy, at 20 centres in Europe and the US.
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