Medtronic starts enrollment in trial for ECG Belt for heart failure therapy
Medtronic announced first enrollments in a new clinical trial evaluating the ECG Belt Research System, ECG Belt, as a diagnostic tool for optimizing cardiac resynchronization therapy, CRT,for patients with heart failure. The first patient enrolled in the ECG Belt for CRT Response trial was at Mercy Medical Center - West Lakes in Des Moines, Iowa, by Troy Hounshell, D.O., Iowa Heart Center. The ECG Belt is investigational and not approved for sale in the United States. 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."