St. Luke’s Medical Center and the Texas Heart Institute Become First in Houston to Implement New Approach for Treating Heart Failure
St. Luke's Medical Center (SLMC) and the Texas Heart® Institute have become the first in Houston to treat a patient suffering from congestive heart failure (HF) with a new implantable electrical device designed to improve heart function.
The CardioFit system - previously tested in Europe - use in the United States is part of a global investigational study to determine its safety and efficacy. The study, INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), will evaluate the system’s ability to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
On November 5, SLMC implanted its first patient with the CardioFit® system in the INOVATE–HF study conducted by Reynolds Delgado, MD, Medical Director of the Heart Failure Mechanical Assist Devices program at THI. Patients enrolled in the study will be randomly assigned to one of two groups: a control group and an active group. Both groups will be closely monitored over the next two years and will receive standard optimal medical therapy, while the active group will also receive the study device implant.
HF is a serious condition in which the heart is unable to provide adequate blood flow to the body. Affecting approximately 23 million people worldwide, 2 million new cases of HF are diagnosed each year. It is the leading cause of hospitalization in people over 65. It’s also the most rapidly growing cardiovascular disorder in the U.S., affecting more than 6 million. HF is caused by a variety of factors that result in damaged heart muscle, the most common of which are coronary artery disease, prolonged high blood pressure and heart valve disorders.
In patients with HF, the nervous system is out of balance, which leads to added stress on the heart and progressive deterioration of cardiovascular function. The CardioFit system is intended to restore balance by activating a specific part of the nervous system (known as the “parasympathetic” nervous system) to reduce stress on the heart, thereby alleviating HF symptoms and reversing HF deterioration. The system operates by stimulating the vagus nerve on the right side of the neck.
The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The sensor lead is extended from the stimulator to the right ventricle of the heart, and the stimulation lead is extended from the stimulator to the vagus nerve on the right side of the neck. Once activated, the stimulator’s electrical pulses are transferred via the stimulation lead to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. Like a pacemaker, the CardioFit System can be programmed on and off via external wireless communication with the device.
The safety and performance of the CardioFit has 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 was granted in December 2008. The company plans to use the results of INOVATE-HF to support a Premarket Approval (application to the U.S. Food and Drug Administration for market clearance of CardioFit in the U.S.)
Patients who may be eligible for enrollment in the INOVATE-HF clinical trial are those who are 18 years and older, have been diagnosed with HF and are being treated with a combination of medicines, but who continue to have symptoms such as shortness of breath and fatigue.
The study will enroll up to 650 patients globally and will be available in approximately 80 centers in the U.S., including the THI at St. Luke’s Medical Center. For more information, contact St. Luke’s Office of Clinical Research at 832-355-3710 (ocr@stlukeshealth.org), or visit www.StLukesHouston.com/Research or the Texas Heart Institute website at www.texasheart.com.
