CardioMEMS Completes CHAMPION Clinical Trial Study
ATLANTA, June 1 /PRNewswire/ -- The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial met its primary efficacy endpoint with a 30% reduction in heart failure hospitalization rates at 6 months (p<0.001) in heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a tiny, permanent wireless implant.
The results were presented this week at the European Society of Cardiology Heart Failure Congress 2010 in Berlin, Germany, by the principal investigators of the trial: William Abraham, M.D., Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center, and Philip Adamson, M.D., Director of the Heart Failure Institute at the Oklahoma Heart Hospital. The study was sponsored by CardioMEMS, Inc., a medical technology company that has developed a novel wireless sensing and communication technology for the human body.
The CHAMPION trial evaluated the safety and effectiveness of the CardioMEMS heart failure (HF) pressure measurement system in New York Heart Association Class III (NYHA Class III) heart failure patients; these patients experience symptoms of heart failure with only mild exertion. NYHA Class III represents roughly 1.5 million of the six million heart failure patients in the U.S., and historically accounts for nearly half of all heart failure hospitalizations.
The CHAMPION Trial enrolled 550 patients, who had been hospitalized for heart failure in the previous year, at 63 leading heart centers in the U.S. All subjects received the CardioMEMS CHAMPION HF sensor as a permanent pulmon