ATLANTA, Feb. 10, 2011 /PRNewswire/ -- The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial was published online today in The Lancet. CHAMPION demonstrated a 30% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 39% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment. The CHAMPION Trial also met all of its safety and secondary efficacy endpoints.
The CHAMPION trial was a randomized, prospective, multicenter, controlled trial that enrolled 550 patients at 64 leading heart centers in the U.S. The trial was led by Dr. William Abraham at the Ohio State University Medical Center and Dr. Philip Adamson at the Oklahoma Heart Hospital. It evaluated the safety and effectiveness of CardioMEMS' heart failure pressure measurement system in New York Heart Association Class III (NYHA Class III) heart failure patients. NYHA Class III patients represent approximately 30% of the over six million heart failure patients in the U.S. and account for nearly half of all heart failure hospitalizations.
All subjects in the CHAMPION trial had the CardioMEMS heart failure sensor permanently implanted in the pulmonary artery using a simple, catheter-based technique. All patients took daily pulmonary artery pressure readings from home that were transmitted to CardioMEMS' secure patient database. For patients in the treatment group only, healthcare providers were provided access to the pressure readings which were used in the treatment of their heart failure condition. For control group patients, health care providers were denied access to the pressure readings and they continued