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news.Germany based Biotronik has enrolled the first patient in large international, prospective, randomized trial, Impact, to evaluate the company's home monitoring technologies.
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The trial will investigate whether the risk of stroke can be reduced in patients with cardiac devices and asymptomatic atrial fibrillation or AF by early detection of these arrhythmias utilizing company’s home monitoring technologies and a predefined anticoagulation plan.
The study will enroll over 2,700 patients from 100 clinical centers worldwide and will utilize the company’s Lumax family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) with company’s exclusive home monitoring solutions.
The Impact study will further contribute to guidelines regarding anticoagulation for patients with AF and provide information on whether early anticoagulation in patients with AF documented by remote monitoring of cardiac device data can reduce the stroke and systemic embolism rate in this patient population.