Patients have begun to be enrolled in the INOVATE-HF clinical study, a multi-center investigational device exemption trial to evaluate the safety and efficacy of BioControl Medical’s CardioFit system, an implantable electrical stimulation device to improve heart function in congestive heart failure (HF) patients.
The first patient in the INOVATE-HF (Increase of Vagal TonE in Heart Failure) was enrolled at Northwest Texas Heart Hospital in Amarillo, Texas, by study investigator Suresh Neelaguru, MD, according to Yehud, Israel-based BioControl Medical.
According to the company the trial will assess whether combined treatment with CardioFit and drug therapy is more effective than drug therapy alone. The study will support a premarket approval application (PMA) to be sent to the FDA for marketing approval of the device.
The CardioFit device works by activating the parasympathetic nervous system to help reduce stress on the heart, alleviating HF symptoms and reversing HF deterioration by stimulating the vagus nerve in the neck.
The trial will enroll 650 HF patients at 80 sites throughout the U.S. and Europe. Patients will be randomized at a 3:2 ratio to receive CardioFit or ongoing prescription drug therapy. The study’s primary endpoint is time for first occurrence of unplanned HF hospitalization or all-cause death. Safety endpoints will include system-related complications within 90 days of implantation and non-inferiority to prescription drug therapy beyond 90 days.
The CardioFit system includes a stimulator, sensor lead and stimulation lead, which are implanted under the skin of the patient’s chest. Once activated, the stimulator’s electrical pulses are transferred by the stimulation lead to the vagus nerve, and at the same time the sensor lead monitors changes in heart activity and turns stimulation on or off.
A recent 32-patient trial conducted in Germany, Italy, the Netherlands and Serbia evaluating the device showed that patients had improved left ventricular function, heart rate variability and resting heart rates when the CardioFit system was used.
The system was granted a CE mark by the European Union in December 2008.