EBR Systems has launched a clinical trial to evaluate its Wireless Stimulation Endocardially (WiSE) cardiac resynchronisation therapy (CRT) pacing technology for the treatment of heart failure patients.
WiSE is an endocardial system designed to stimulate the left ventricle of the heart to improve pumping ability. It provides pacing through a tiny, wireless, electrode implant.
The ‘Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy’ (SOLVE-CRT) trial is being conducted in a randomised, double-blind setting to assess the safety and efficacy of WiSE.
Around 350 subjects who did not respond to or could not receive standard CRT treatment will be recruited for the trial at up to 45 US, European and Australian sites.
Trial’s global principal investigator Jagmeet Singh said: “Wireless pacing promises to address an important unmet need for patients with heart failure.
“Studies have demonstrated successful cardiac resynchronisation therapy improves symptoms and reduces hospitalisations and mortality, but many patients do not respond to traditional CRT devices and have limited therapeutic options.”
In a previous multi-centre SELECT-LV trial, the WiSE CRT system is reported to have demonstrated persistent clinical benefits at six months in the majority of 39 participants investigated.
The clinical benefits experienced by the patients included freedom from mortality and hospitalisations due to heart failure, and improved quality of life and functional capacity.
EBR Systems chairman and CEO Allan Will said: “We believe SOLVE-CRT to be a landmark study that will build on previous positive results of this first-of-its-kind innovation for heart failure patients.”