Yehud-based BioControl Medical, has received approval from the Israel Ministry of Health to conduct clinical trials of its CardioFit system in patients with chronic heart failure as part of INOVATE-HF.
With the approval, Israel will join European countries and the USA to participate in the company’s third phase of INOVATE-HF (Increase of vagal tone in heart failure), a US Food and Drug Administration-approved investigational device exemption (IDE) study of CardioFit being conducted in 80 centres worldwide.
The press release explains that INOVATE-HF is a prospective, controlled clinical study to determine the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function and the first medical device to treat chronic heart failure using neurostimulation. The study will evaluate the system’s potential to reduce hospitalisation and death among patients with heart failure, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
Three medical centres will participate in the study: Barzilai in Ashqelon; Bnai-Zion (Rothschild) in Haifa; and Kaplan in Rehovot. Patients diagnosed with Class III heart failure caused by left ventricular dysfunction who routinely take prescription drug therapy may qualify to participate in the trial. Patient recruitment is already underway.
“INOVATE-HF is an incredibly important trial that could offer new hope to patients with heart failure and provide medical professionals with new insights into how to treat and prevent the progression of the disease,” says Uri Rosenschein, director of the department of cardiology, Bnai-Zion Medical Centre and a lead investigator in the trial. “We are honoured to be part of a potentially groundbreaking clinical trial for a product that was designed and developed in Israel.”