of BIOTRONIK Home Monitoring® Guided Anticoagulation on Stroke Risk in Patients with ICD and CRT-D Devices is a clinical trial investigating whether the risk of stroke can be reduced in patients with cardiac devices and asymptomatic atrial fibrillation by early detection of these arrhythmias utilizing BIOTRONIK Home Monitoring® and a predefined anticoagulation plan.
IMPACT is a prospective, multicenter, randomized (1:1), single-blinded, parallel group, international trial. It has been designed to test the hypothesis that initiation and withdrawal of oral anticoagulant therapy guided by continuous ambulatory monitoring of the atrial intracardiac electrograms improve clinical outcomes by reducing the combined rates of stroke, systemic embolism, and major bleeding compared to conventional clinical management.
The major secondary endpoints include, total mortality, ischemic and hemorrhagic stroke event rates, fatal or disabling and non-disabling stroke event rates, major bleeding event rates, AF burden and QoL.
Key inclusion criteria are adult patients implanted with a BIOTRONIK Lumax HF-T or DR-T device, documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrolment, if previously implanted, NYHA class I or II and CHADS2 risk score ≥ 1.
The IMPACT trial will enroll over 2,700 patients from 100 investigational sites worldwide and will utilize the BIOTRONIK Lumax series of ICDs and CRT-D devices along with BIOTRONIK Home Monitoring® systems.
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. Remote monitoring of cardiac device data may be particularly relevant in patients with asymptomatic AF by allowing timely intervention as compared to conventional periodic in-office evaluation.
Ip, J, et al. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort: The IMPACT study. Am Heart J 2009;158:364-370.e1.