BERLIN--(Marketwired - May 23, 2013) - BIOTRONIK
, a leading manufacturer of innovative medical technology, announced today that enrollment has been completed for the highly anticipated IMPACT study
. The study 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.
2,718 patients at 100 clinical sites in the US, Canada, Germany, Australia, the UK, and Denmark have been enrolled in this randomized, international, multi-center trial.
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 randomized 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 Prof. Jonathan Halperin, MD, Mount Sinai Medical Center, New York 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 both stroke and bleeding, as well as improving the clinical outcomes of patients at risk of atrial fibrillation."
Co-Principal Investigator Dr. John Ip, MD, Sparrow Clinical Research, Lansing, Michigan added, "IMPACT is the largest prospective study of implanted defibrillator patients being monitored for atrial high rate episodes and AF. 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 AF disease progression and its relationship to stroke risk."
BIOTRONIK Home Monitoring® rapidly detects anomalies in patients' cardiac health, continuously transmits data on a daily basis and notifies medical staff with appropriate alerts without the need for any patient interaction. The early detection of clinically relevant events, including the duration of atrial fibrillation and the advantageous detection of asymptomatic events, enables the physician to adapt patient therapy at a very early stage.
"Presently, guidelines surrounding anticoagulation only address the medical history of the patient and do not include recommendations for device-detected AF. 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."
IMPACT is registered on clinicaltrials.gov, NCT #00559988.
About BIOTRONIK SE & Co. KG
As one of the world's leading manufacturers of cardiovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5600 employees. Several million heart patients around the world have received BIOTRONIK implants, designed to save and improve the quality of their lives. Since its development of the first German pacemaker in 1963, BIOTRONIK has launched several innovations into the market -- including remote monitoring with BIOTRONIK Home Monitoring® in 2000 and the world's first implantable cardioverter-defibrillators and implantable heart failure therapy devices with ProMRI® technology, approved for MR scanning, in 2012. In 2013, BIOTRONIK will be celebrating its 50th anniversary.
For more information: www.biotronik.com
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