May 18, 2009 – At Heart Rhythm 2009 last week Biotronik said it completed the first enrollment in the pivotal phase of its IMPACT clinical study, which 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.
The IMPACT study is an international clinical trial using Biotronik’s remote monitoring technologies in conjunction with its Lumax HF-T and DR-T defibrillators and a predefined anticoagulation plan. The devices can be used with Biotronik’s Home Monitoring, which provides the physicians with automatic, remote updates on their patients’ cardiovascular and device status.
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.
"IMPACT is a unique study,” said 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 John J. Ip, M.D., electrophysiologist at the Thoracic and Cardiovascular Health Care Foundation in East Lansing, Mich., 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.”
For more information, visit www.biotronik.com.