PATIENT INFORMATION
CARDIOFIT™ SYSTEM TRIAL FAQ
BioControl Medical has completed enrollment for the European pilot study of the CardioFit system. Please check back for updated information on other BioControl's clinical studies.
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BioControl Medical specializes in the development and marketing of advanced implantable devices for the treatment of autonomic disorders. These are conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes such as heart rate, blood pressure, body temperature, breathing rate, digestion and endocrine secretions.
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Vagus is the Latin word for wandering. True to its name the vagus nerve wanders from the brainstem down to the colon supplying nerve fibers and regulating the functions of the various organs on its path, including the heart, inducing a “relaxing” effect on the heart muscle. Stimulation of the vagus nerve is a proactive way to induce a therapeutic effect. Vagus nerve stimulation is currently an accepted and effective treatment for people suffering from epilepsy and depression.
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BioControl’s CardioFit system is a new electrical stimulator system designed to improve heart function. Pre-clinical data and preliminary clinical data demonstrate that vagus nerve stimulation has a therapeutic value in treating heart failure. It may be able to reduce the heart’s rate, restore regular rhythm and reduce inflammation. Historical data shows that vagus nerve stimulation may also increase blood flow to the heart, reduce the relative risk for death and can be beneficial to patients under beta blockade by complimenting known drug therapies.
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The clinical study titled “CardioFit for Heart Failure” is designed to investigate the safety and efficacy of the CardioFit system. The trial is the first to test safety and performance of nerve stimulation for the treatment of a non-neurological disorder. Enrolled patients will be invited to actively remain in the study for six months. Each patient’s recovery will be followed for up to one year.
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The CardioFit system trial will enroll between 20-30 patients between 18 and 75 years of age who meet the inclusion/exclusion criteria.
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The CardioFit system consists of a neurostimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The stimulator’s electrical pulses are transferred via the stimulation lead to the vagus nerve in the neck. The electrode placed in the heart (the sensor lead) monitors the heart rate and adapts the therapy accordingly. The implanted neurostimulator includes a microcomputer that analyzes information from the heart and decides on the appropriate stimulation needed at the vagus nerve. This stimulation is carried through an electrode from the implanted neurostimulator to the vagus nerve in the neck. The CardioFit treatment is completely reversible and the system can be turned off and/or removed from the body at any time.
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Implantation of the CardioFit system includes (i) Implantation of the electrostimulation lead (vagus nerve lead) in the neck; (ii) implantation of the sensor lead (intracardiac ventricular lead, similar to that of a pace-maker) through a vein in the chest into the right side of the heart and (iii) implantation of the CardioFit neurostimulator under the skin of the chest. Discharge from the hospital is anticipated for the next day.
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Following the implantation, enrolled patients will be requested to return for one-hour check ups for three weeks. These will be followed by five additional check ups for a six month period. Follow up visits include tests that are similar to those conducted at baseline; however, not all tests will be conducted at each visit. At the end of the first six-month period, the patient will be invited back to the clinic for a check up once every six months thereafter.
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Pre-clinical study data show that the CardioFit system may provide a therapeutic effect on cardiac patients and supported the commencement of clinical trials in people suffering from heart failure. The CardioFit system trial is currently enrolling patients.
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BioControl Medical, the study sponsor, will pay for all medical and related expenses associated with trial participation.
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Click here for a list of participating study sites and principal investigators.
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