Vectorious Begins VECTOR-HF FIH Trial to Support European Approval of V-LAP Device
February 4, 2019—Vectorious Medical Technologies Ltd. announced the initiation of the VECTOR-HF first-in-human (FIH) clinical trial. The VECTOR-HF FIH trial will enroll up to 30 patients at six sites in Germany, Italy, the United Kingdom, and Israel.
The prospective, multicenter, single-arm, clinical trial is designed to assess the safety and performance of Vectorious' sensory device for measuring left atrial pressure (LAP). The trial will support CE Mark approval of the company's V-LAP system.
According to Vectorious, the V-LAP system is a digital, wireless, batteryless microcomputer that transmits data using high-resolution waveform morphology. The feedback provided by the V-LAP will enable improved management of patients with heart failure. Patients who undergo V-LAP implantation will be able to measure LAP daily at home via an easy, noninvasive method using a small, portable external unit. Physicians receive daily readings of patient hemodynamic pressure to provide early, accurate physiological indication of cardiac decompensation.
Vectorious advised that the initial implantation of the device in the FIH trial was completed in 6 minutes. The V-LAP device was fixed in the patient’s interatrial septum using a standard percutaneous procedure under fluoroscopy and echocardiographic guidance, with the application of local anesthesia. Professor Horst Sievert, MD, Director of the CardioVascular Center Frankfurt in Frankfurt, Germany, performed the procedure.
In the company's announcement, Prof. Sievert commented, “This technology will really change the way we manage patients with severe heart failure. This is the first device that specifically enables us to monitor pressure within the left side of the heart; and because of its cloud-based system, we can access patient data on-demand, monitoring the atrial pressure and managing dosages, medications, and overall quality of life consistently and remotely.”
William T. Abraham, MD, stated, “The increase of LAP is the most specific and earliest sign of impending heart failure exacerbation—long before clinical symptoms occur. V-LAP’s unmet clinical need has been evident for years, and the cardiology profession will benefit greatly from the availability of technology that can provide this valuable indication noninvasively on a daily basis.”