Nerve Stimulation Eases Chronic Heart Failure Symptoms

Researchers at Lancaster General Hospital (LGH; PA, USA) are conducting the INOVATE-HF global investigational clinical trial to determine the safety and effectiveness of the CardioFit system—a product of BioControl Medical (Yehud, Israel)—implantable device, which comprises a sensing lead attached to the heart and a stimulation lead looped around the vagus nerve, part of the parasympathetic nervous system. The system works by sending electrical pulses to the vagus nerve, which paces the heart using a feedback mechanism, thus helping to regulate and improve heart function in CHF patients by lessening cardiac stress.

The safety and performance of the CardioFit have previously been validated in a 32-patient, multicenter, pilot clinical study conducted in Germany, Italy, The Netherlands, and Serbia. Study data showed that patients experienced sustained significant improvement across key clinical measures including left ventricular function and structure, heart rate variability, and resting heart rate. The patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests. The results of the European pilot study were used to support filing for CE marking certification of the CardioFit system in the European Union.

“A growing body of research is demonstrating a connection between the heart and brain that could benefit heart failure patients,” said Roy Small, MD, director of Heart Failure Services at LGH, who is leading the study. “The study is being conducted to learn whether the device will ease heart failure symptoms and reverse deterioration.”

“Early experiments with the device show promise of being able to significantly improve the patient's heart function and quality of life when used with standard treatments,” said Steven Woratyla, MD, chief of the division of vascular surgery at LGH. “The study will tell us whether the combination of the implanted device and medical therapy is more effective than medical therapy alone in treating congestive heart failure.”

CHF currently affects approximately 23 million people worldwide and is diagnosed in two million new cases each year. Most CHF patients are treated with prescription drugs that are successful at managing select symptoms, but are ultimately unable to stop heart failure deterioration.

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BioControl Medical
Lancaster General Hospital