Anita Levy, 59, arrived at Massachusetts General Hospital in 2012 with severe heart failure. The mother of four, grandmother of eight and wife of 38 years, was starting to lose hope. After trying a number of therapies without success, her doctors informed her she was a candidate for a new clinical trial.
She's the first Mass. General patient and first person in New England to be enrolled and to have underwent surgery as part of INOVATE-HF, a randomized study testing the safety and efficacy of CardioFit® for the treatment of patients with heart failure and left ventricular dysfunction.
CardioFit® is an implantable electrical stimulation device designed to restore balance in the autonomic nervous system and improve heart function in patients with heart failure. The device activates the parasympathetic branch of the autonomic nervous system for the treatment of heart failure by stimulating the vagus nerve on the right side of the neck. Vagal nerve therapy has principally been used to help treat patients with epilepsy and depression.
This therapy is for patients who haven't responded well to traditional treatments and have severe heart failure symptoms. The trial is evaluating the device's ability to reduce hospitalization and death among heart failure patients. A 32-patient, multi-center, pilot clinical study was conducted in Europe, and data showed patients experienced significant improvement across clinical measures including left ventricular function and structure, heart rate variability and resisting heart rate. Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests.
In 2010, there were approximately 5.8 million people in the United States with the diagnosis of heart failure. Each year, approximately 670,000 people are diagnosed with heart failure, and more than 290,000 deaths are associated with the disease. It is more common in people over the age of 65, and it is the number one reason why people over the age of 65 are hospitalized.
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