The global, multicenter randomized clinical trial called INOVATE-HF (INcrease Of VAgal TonE in chronic Heart Failure) is investigating the safety and efficacy of an implantable vagus nerve electrical stimulation device called CardioFit to improve the heart's function and the quality of life of heart failure patients.
Mount Sinai's multidisciplinary team of clinical trial investigators includes principal investigator electrophysiologist Vivek Reddy, MD, Director of Arrhythmia Services; neurosurgeon Brian H. Kopell, MD, Director of the Center for Neuromodulation; and heart failure specialist Ajith P. Nair, MD, Director of the Pulmonary Hypertension Program in the Advanced Heart Failure and Transplantation Program.
The device is a three-part system consisting of a "stimulator" about the size of a pacemaker, and two connecting leads.
The stimulator is implanted under the skin of the chest with a "sensor lead" implanted inside the right ventricle of the heart, and a "stimulation lead" implanted around the vagus nerve in the right side of the neck.
The large vagus nerve runs from the brain stem down to the abdomen on both the left and right side of the body.
It sends signals throughout the body and directly to and from the brain to regulate multiple bodily functions including heart rate.
Once activated by doctors, the stimulator in the chest sends mild electrical pulses up to the vagus nerve to help reduce heart rate, stress, and workload on the cardiac muscle to improve overall heart function.
The sensor lead in the heart's right ventricle monitors for any abnormal changes in the heart's electrical activity and provides feedback to the stimulator enabling it to react.
"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," Dr. Vivek Reddy, Director of Arrhythmia Services at The Mount Sinai Hospital, said.
"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. I am excited that by working with our heart failure and neurosurgery colleagues, we can offer this potentially transformative therapy to our patients," he said.
--ANI (Posted on 03-11-2013)