The Ohio State University Wexner Medical Centre has launched a groundbreaking clinical trial to assess a device’s effectiveness in alleviating heart failure symptoms. The initial patient, a 54-year-old Ohio man with severe shortness of breath due to heart failure, was randomised into the trial. This device, first implanted in an early feasibility study in April 2022, is now under investigation on a larger scale, marking a significant milestone in cardiac research. Heart failure, which affects 6.2 million individuals in the U.S., is a leading global cause of hospitalizations. The trial targets heart failure with preserved ejection fraction (HFpEF), characterised by stiff heart muscles leading to symptoms such as shortness of breath and fatigue. The device aims to reduce left heart pressure, alleviating these symptoms. Implanted through a catheter, it preserves the interatrial septum, making it valuable for patients with atrial fibrillation and a leaky mitral valve. Ohio State’s Richard M. Ross Heart Hospital aims to recruit 100 patients at 30 investigational sites in this randomised, double-blinded study in partnership with Edwards Lifesciences, the device’s manufacturer.
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