The CardioMEMS Heart Sensor CHAMPION that facilitates pressure monitoring for improving the outcomes of the trial conducted on the NYHA Class III patients, has achieved its crucial efficacy endpoint. A 30% decrease in heart failure patients’ hospitalization rates for six months (p<0.001) has been achieved. The treatment of the patients involved in the trials was made possible by obtaining pulmonary artery pressures with the help of a miniaturized, permanent wireless implant.
The trial’s principal investigators presented the trial results at the European Society of Cardiology Heart Failure Congress 2010 in Berlin. These investigators include Director of the Division of Cardiovascular Medicine, William Abraham, M.D. at the Ohio State University Medical Center, and Director of the Heart Failure Institute, Philip Adamson, M.D., at the Oklahoma Heart Hospital. A medical technology company CardioMEMS, sponsored this study related to a new communication and wireless sensing technology for the patient’s body.
The CHAMPION trial had assessed the effectiveness and safety of the heart failure (HF) pressure measurement system of CardioMEMS while treating heart patients under the New York Heart Association Class III category. These patients suffer from heart failure symptoms even with mild exertion. The NYHA Class III category accounts for about 1.5 million out of the total six million heart failure patients in the U.S. and historically accounts for about 50% of total heart failure hospitalizations.
550 patients who were hospitalized in the previous year were enrolled for the CHAMPION trial at 63 leading U.S. heart centers in the U.S. All the patients were provided with the CardioMEMS CHAMPION HF sensor. This sensor was in the form of permanent pulmonary artery implant. The patients were randomized with a control or a treatment group before discharge. Before enrolling for the CardioMEMS trial, they were under treatment by heart failure specialists in leading centers and were being provided with device, drug, and disease management therapy.