The IMPACT study is an international clinical trial that investigates whether the risk of stroke can be reduced in patients being treated for atrial fibrillation with cardiac devices through early detection of these arrhythmias using BIOTRONIK’s remote monitoring technologies in conjunction with BIOTRONIK’s industry-leading Lumax HF-T and DR-T defibrillators and a predefined anticoagulation plan. The state-of-the-
The IMPACT study began in 2008 with the technical feasibility phase, which included 227 patients and 27 sites. The pivotal phase, the next stage of the study, will include up to 100 sites and 2,700 patients randomized to the study.
Movement of the IMPACT study into the pivotal phase demonstrates the technical feasibility and sound logistical design of the study, and that the defined markers of success in the roll-out phase have been met. It also affirms that the study’s steering committee and data safety monitoring board, both comprised of independent physicians, have validated the success of the original study design.
"IMPACT is a unique study,” said Dr. Albert L. Waldo, M.D., professor of medicine and professor of biomedical engineering at Case Western Reserve University in Cleveland, Ohio. “By using BIOTRONIK Home Monitoring capabilities, the medical community has the potential to change how we administer anticoagulants in patients with atrial tachycardia, who are at risk for stroke."
Dr. Waldo is a member of the IMPACT Steering Committee.
“Through the IMPACT study, we hope to gain insight for optimal treatment of patients with atrial fibrillation and heart failure,” said Dr. John J. Ip, M.D., electrophysiologist at the Thoracic and Cardiovascular Health Care Foundation in East Lansing, Michigan, and IMPACT Steering Committee co-chairman. “By using device data with the BIOTRONIK Home Monitoring system, it may be possible to record and interpret the timing of atrial fibrillation and efficacy of early anticoagulation therapy in an aging population.”
Jake Langer, president of BIOTRONIK Inc., affirmed the company’s leadership role in conducting landmark clinical studies. “We are committed to advancing scientific inquiry and to ensuring the safe and effective use of CRM devices by supporting large, well-controlled studies within the United States,” stated Langer. BIOTRONIK is currently supporting six other large scale clinical trials in addition to the IMPACT study: EchoCRT, CLEAR, REPLACE, GALAXY, CELESTIAL and TRUST. All BIOTRONIK clinical studies are registered online at www.clinicaltrials.gov.
For more information, visit www.biotronik.com.
As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4,500 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.
Contact: Joel Salzberg
Public Relations
503.675.2156
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