Medtronic has started enrolment in a clinical trial intended to evaluate its ECG Belt Research System as a diagnostic to optimise cardiac resynchronisation therapy (CRT) for heart failure.
Referred to as ECG Belt for CRT Response, the prospective, randomised, interventional trial is designed to initially compare CRT and ECG Belt diagnostics treatment with standard CRT in ten subjects.
Medtronic plans to expand the trial to additional sites globally to recruit a total of 400 patients. The first participant has been enrolled at the Mercy Medical Center in the US.
First site principal investigator Troy Hounshell said: “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.
“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.”
During the trial, the ECG Belt will be used for synchronisation measurements in real-time in order to evaluate the electrical activity of the heart.
The diagnostic tool will be applied during the implantation of a CRT device. The Belt will be externally wrapped around the patient’s chest and back to guide the left ventricular lead placement.
ECG Belt will be additionally used at follow-up visits to perform further optimisation of the device’s programmed settings.
Medtronic Cardiac Resynchronization Therapy business vice-president and general manager Kweli Thompson said: “Our goal for this study is to give clinicians real-time insights to address each patient’s needs and to help optimise CRT for heart failure patients.”