Catheter Precision has announced the initiation of a pivotal clinical trial to assess the accuracy and safety of the VIVO (View Into Ventricular Onset) Non-Invasive Mapping System. The VIVO system is designed to provide pre-procedure guidance to the cardiologist by identifying the area of the heart where the abnormal rhythm initiates. The ability to target the area of arrhythmia onset should minimize the need for multi-hour invasive mapping prior to the ablation procedure, ultimately reducing overall procedure time.

The first study subjects have been enrolled at the University of Iowa Hospitals and Clinics and Johns Hopkins University School of Medicine. It is expected that the study will expand to five US hospitals and enroll up to 60 patients.

"We are pleased to be working with the physicians at these prestigious institutions on this study. Identification of the location where arrhythmic signals originate can take several hours. Reducing the time to ablation should reduce the time it takes the physician to successfully treat cardiac arrhythmias," said Steve Adler, President and chief executive officer of Catheter Precision Inc. Arrhythmias or irregular heart rhythms affect millions of Americans and certain types are potentially life threatening; some arrhythmias can be effectively treated with ablation. During ablation, a small area of the cardiac tissue associated with the arrhythmia is scarred or destroyed so it can no longer send out the electrical signals causing the arrhythmia. Ablation is preceded by cardiac mapping, a time-intensive procedure aimed at pinpointing the precise location where the arrhythmic signals originate.

"This study follows the successful work at Hopkins of 20 subjects evaluating the accuracy of the VIVO system," stated Hari Tandri, MD, Associate Professor of Medicine at Johns Hopkins University Hospital. "In our experience VIVO was able to predict the location of earliest activation of PVCs and the potential exit site of VT with good accuracy."

Upon completion of the use of the VIVO system on the first study subject, Alexander Mazur, MD, Clinical Professor at the University of Iowa, commented, "VIVO is a promising new technology and may provide us better data about the source of the arrhythmia. I look forward to where this technology can take arrhythmia treatment in the future."

The study was developed in accordance with FDA input on the trial design, and the results from this clinical study will be included in a submission to the FDA for 510(k) clearance of the VIVO system.  The VIVO system has achieved a CE Mark allowing it to be commercialized in the European Union and been placed at several hospitals in Europe.

The VIVO system is a software product that includes a laptop computer and 3D camera.  Using non-invasive clinical inputs (12-lead ECG, cardiac magnetic resonance image or computed tomography) and a 3D image of the patient's torso, VIVO combines patient-specific images (MRI or CT) of the torso and cardiac structures and a 3D image of the torso that identifies precise ECG lead placement to generate a 3D model of the patient's heart with a superimposed activation map. When an arrhythmic beat is selected from the ECG, the VIVO algorithm is designed to determine the activation origin or onset location.