A Medical Device Daily

Biotronik (Lake Oswego, Oregon) reported the launch of the Impact Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with Implanted ICD and CRT-D devices (IMPACT) study, the first enrollee implanted at the Thoracic & Cardiovascular Institute (Lansing Michigan).

IMPACT will investigate whether the risk of stroke can be reduced in patients with cardiac devices and asymptomatic atrial fibrillation (AF) by early detection of these arrhythmias using Biotronik’s Home Monitoring technologies and a predefined anticoagulation plan.

IMPACT will enroll over 2,700 patients from 100 clinical centers worldwide and will use the Biotronik’s Lumax family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) with Biotronik’s home monitoring solutions. The study will provide information on whether early anticoagulation in patients with AF documented by remote monitoring can reduce the stroke and systemic embolism rate in these patients, compared to conventional in-office evaluation.