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Trial to assess vagus nerve stimulation for reduction of HF symptoms

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A multidisciplinary team of experts in HF, arrhythmia disorders and neurosurgery at Mount Sinai Hospital are conducting a trial to evaluate use of an electrical device that stimulates the vagus nerve in the neck to reduce symptoms associated with HF.

For the multicenter, international, randomized INOVATE-HF clinical trial, researchers will assess the efficacy and safety of the implantable CardioFit (BioControl) device in a cohort of patients with HF. The trial will determine the impact of the device on arrhythmias, fatigue and dyspnea, hospitalization and mortality as compared with standard combination therapy. Eligible patients have NYHA class III HF and debilitating symptoms despite treatment with combination therapy, according to a press release.

INOVATE-HF is the first in the US to assess vagus nerve stimulation in a population of patients with HF.

Prior studies have indicated that the CardioFit device can improve heart function, quality of life and increase exercise tolerance within weeks of implantation.

CardioFit includes an implantable pacemaker-sized stimulator, with a stimulation lead placed around the vagus nerve and a sensor lead inside the right ventricle. Mild electrical pulses to the nerve are delivered and the sensor monitors abnormalities in the heart’s electrical activity, allowing for the stimulator to react accordingly, according to the release.

“This novel use of vagus nerve stimulation may be the therapy we have long been waiting for to bring relief to heart failure patients with chronic symptoms and protect them from dangerous and potentially fatal arrhythmias,” Vivek Y. Reddy, MD, director of arrhythmia services at Mount Sinai Hospital, stated in the release. “The results of this study testing the simple electrical stimulation of the body’s powerful vagus nerve may unlock a future promising therapy for heart failure.”

Disclosure: The trial is sponsored by BioControl. The researchers report no relevant financial disclosures.