New Nerve Stimulation Treatment Study at LGH Designed to Ease Chronic Heart Failure Symptoms in Patients
Published: Dec 20, 2012
The INOVATE-HF global investigational clinical trial to determine the safety and effectiveness of the CardioFit® system designed to improve the heart function in patients with heart failure, is being conducted here locally by the hospital's Heart & Stroke Foundation.
Roy Small, M.D., director of Heart Failure Services, who is leading the study at LGH, said the new electrical device is the first to treat the heart through nerve stimulation, a completely new mechanism of action. "A growing body of research is demonstrating a connection between the heart and brain that could benefit heart failure patients," he explained. "The study is being conducted to learn whether the device will ease heart failure symptoms and reverse deterioration."
Steven P. Woratyla, M.D., who is chief, division of Vascular Surgery, and Seth Worley, an eclectrophysiologist and director of the LGH's Interventional Implant Program, implanted the first CardoFit system in a 66-year-old man on Tuesday, Dec. 18. Dr. Worley said the device is implanted under the skin of the chest and attached to the heart, like a pacemaker, and is also connected to a nerve in the neck. "It works by sending electrical pulses to the vagus nerve, which sends signals to the heart, that helps regulate and lessens the stress on the heart."
While Dr. Worley will implant the sensing lead into the heart, Dr. Woratyla will surgically implant the stimulation lead around the vagus nerve in the neck.
"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 Dr. Woratyla. "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."
The procedure will be performed in the hospital's new Hybrid Operating Room, The Lancaster Heart & Vascular Institute's latest technological offering. The Hybrid OR is designed to combine the capabilities of a cardiac catheterization lab with a cardiac surgery operating room for patients who need complex cardiovascular surgeries.
Patients participating in the study must be age 18 or older, diagnosed with congestive heart failure and suffering from heart failure symptoms, such as shortness of breath or fatigue despite treatment, with a combination of medicines. For more information, or for persons interested in taking part in the study, please call Heart Failure Clinical Trials at 717-290-6681.
About Heart Failure
HF currently affects approximately 23 million people worldwide and is diagnosed in two million new cases each year, according to World Market Research. The leading cause of hospitalization in people over age 65, HF is also the most rapidly growing cardiovascular disorder in the United States (American Heart Association). Most HF patients are treated with prescription drugs that are successful at managing select symptoms but are ultimately unable to stop HF deterioration. CardioFit was developed to address this unmet clinical need by directly activating a specific part of the body's nervous system (called the "parasympathetic" nervous system) to reduce stress on the heart, thereby alleviating HF symptoms and reversing HF deterioration. It operates by stimulating the vagus nerve on the right side of the neck.
The safety and performance of the CardioFit have been validated in a 32-patient, multi-center, 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. Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests. The results of this pilot study supported BioControl Medical's filing for CE mark certification to market and sell CardioFit in the European Union, which it was granted in December 2008.