ECG Belt for CRT Response is a prospective, randomized, interventional, investigational study that will initially enroll patients in 10 centers across the U.S. The trial will compare patients treated with CRT and ECG Belt diagnostics to patients treated with standard CRT. The study will expand to additional sites worldwide to ensure a total of 400 randomized patients.
CRT is an established treatment option for indicated patients with heart failure in which an implantable device sends low levels of energy through thin wires, called leads, to stimulate the lower chambers of the heart to improve its pumping efficiency. The therapy has been demonstrated to improve survival and quality of life, and to reduce hospitalizations.
"The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits," said Dr. Hounshell, electrophysiologist at Iowa Heart Center, and the site's principal investigator in the study. "By pairing CRT with the ECG Belt, we have the potential to provide a more personalized and noninvasive approach to help heart failure patients."
Using the ECG Belt during the trial, clinicians will assess the heart's electrical activity through real-time synchronization measurements. At the time of CRT device implant, the ECG Belt will be applied externally to patients' bodies, wrapped around the chest and back, to help physicians guide placement of the left ventricular lead. The ECG Belt will be used again at follow-up visits to further optimize the device's programmed settings.
"Our goal for this study is to give clinicians real-time insights to address each patient's needs, and to help optimize CRT for heart failure patients," said Kweli P. Thompson, M.D., M.P.H., vice president and general manager of the Cardiac Resynchronization Therapy business, which is part of the Cardiac Rhythm and Heart Failure division at Medtronic.
The Medtronic portfolio of therapies, diagnostic tools and services for patients suffering from heart failure includes CRT devices, including MR-conditional CRT-Ds and CRT-Ps; mechanical circulatory support therapy for advanced heart failure patients; heart failure diagnostics; and meaningful expert analysis through Medtronic Care Management Services.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Medtronic strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.