CHAMPION Study of CardioMEMS Heart Sensor Published

February 10, 2011—CardioMEMS, Inc. (Atlanta, GA) announced that results of the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial have been published by William T. Abraham, MD, et al online ahead of print in The Lancet.

The CHAMPION trial is a randomized, prospective, multicenter, controlled trial that enrolled 550 patients at 64 leading heart centers in the United States. It evaluated the safety and effectiveness of CardioMEMS' heart failure pressure measurement system in New York Heart Association (NYHA) class III heart failure patients. CardioMEMS noted that NYHA class III patients represent approximately 30% of the more than 6 million heart failure patients in the United States and account for nearly half of all heart failure hospitalizations. Dr. Abraham and Philip Adamson, MD, are the trial's principal investigators.

According to CardioMEMS, 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. 



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, which were transmitted to CardioMEMS' secure patient database. For patients in the treatment group only, health care providers were given 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 to receive standard care.

"The results from the CHAMPION study are very significant and provide a valuable new tool in the battle against heart failure," commented Dr. Abraham. "Pulmonary artery pressure monitoring is the first major device breakthrough in heart failure since CRT therapy."

Dr. Adamson added, "The CHAMPION trial illustrates how close monitoring of patients with chronic heart failure can reduce the need for costly and dangerous hospitalization while improving quality of life. These results are the beginning of a new era of hope for patients suffering from chronic symptomatic heart failure complementing medical and device therapies. The ‘hemodynamic era' is a major advancement with promise for profound long-term impact on heart failure morbidity.”



As reported in Cardiac Interventions Today, St. Jude Medical, Inc. (St. Paul, MN) acquired a 19% equity ownership interest in CardioMEMS in September of 2010, with an exclusive option to acquire the remaining 81%. Cardiologist Jay Yadav, MD, is the founder and chief executive officer of CardioMEMS. The CardioMEMS Heart Sensor is an investigational device limited by federal law to investigational use in the United States.