Medtronic has announced the first enrolments in a new clinical trial evaluating the ECG (electrocardiography) Belt Research System (ECG Belt) as a diagnostic tool for optimising cardiac resynchronisation therapy (CRT) for patients with heart failure. The first patient enrolled in the ECG Belt for CRT Response trial was at Mercy Medical Centre, Des Moines, USA, by Troy Hounshell, D.O., Iowa Heart Centre. The ECG Belt is investigational and not approved for sale in the United States.
ECG Belt for CRT Response is a prospective, randomised, interventional, investigational study that will initially enrol patients in 10 centres 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 randomised 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 hospitalisations.
“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 Hounshell, electrophysiologist at Iowa Heart Centre, and the site’s principal investigator in the study. “By pairing CRT with the ECG Belt, we have the potential to provide a more personalised and non-invasive approach to help heart failure patients.”
Using the ECG Belt during the trial, clinicians will assess the heart’s electrical activity through real-time synchronisation 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 optimise the device’s programmed settings.