On 24 May, Biotronik announced it has completed enrolment for the IMPACT study, which aims to investigate whether the use of Biotronik Home Monitoring in conjunction with anticoagulation can reduce the risks of stroke, systemic embolism and major bleeding in cardiac device patients.
In this randomised, international, multicentre trial, 2,718 patients at 100 clinical sites in the USA, Canada, Germany, Australia, the UK, and Denmark were enrolled.
Participants in the study have been implanted with a Biotronik Lumax DR-T/HF-T device with Biotronik Home Monitoring. IMPACT will compare patient outcomes between two randomised groups. The first group is being continuously monitored for symptomatic or asymptomatic atrial fibrillation using Biotronik Home Monitoring, and subsequently treated using a pre-defined anticoagulation plan. The second group is receiving conventional device evaluation at in-office follow-up visits for detection of atrial fibrillation events and physician-directed anticoagulation based on the patient’s medical history. The study design was published in the American Heart Journal, September 2009.
Co-principal investigator Jonathan Halperin, Mount Sinai Medical Center, New York, USA, said: “Atrial fibrillation occurs more commonly in patients with cardiac disease than in the general population, and is associated with a substantial risk of stroke. While anticoagulant therapy is highly effective at preventing stroke, it carries a risk of bleeding. IMPACT is the first trial to evaluate remote monitoring in patients with implanted cardiac pacemaker-defibrillators. This study will determine whether surveillance of cardiac rhythm on a day-to-day basis to guide therapy may reduce the rates of stroke and bleeding, as well as improving the clinical outcomes of patients at risk of atrial fibrillation.”
Co-principal investigator John Ip, Sparrow Clinical Research, Lansing, Michigan, USA, added: “IMPACT is the largest prospective study of implanted defibrillator patients being monitored for atrial high rate episodes and atrial fibrillation. This large amount of data from the enrolled 2,718 patients in this study may also give the medical community a much better understanding of atrial fibrillation disease progression and its relationship to stroke risk.”
“Presently, guidelines surrounding anticoagulation only address the medical history of the patient and do not include recommendations for device-detected atrial fibrillation. Continuous device monitoring is vital in obtaining accurate data for targeted anticoagulation therapy,” said Christoph Böhmer, president international at Biotronik. “The IMPACT study will provide highly valuable insights into whether remote monitoring in combination with anticoagulation will allow for faster intervention and prevention of stroke in cardiac device patients. This in turn could lead to a significant change in clinical practice and make a real difference in the lives of patients.”