VIVO Accuracy study
Research type
Research Study
Full title
VIVO Accuracy Study
IRAS ID
249407
Contact name
Missiaen Huck
Contact email
Sponsor organisation
Catheter Precision, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Accurate localization of the origin of focal heart rhythm disturbances, such as premature ventricular complexes (PVCs) or ventricular tachycardia (VT) is a prerequisite to successful treatment with a heart procedure such as catheter ablation. Mapping and determining the foci of such arrhythmias is time consuming, invasive and difficult, especially in the case of determining the foci of a ventricular arrhythmia. \n\nVIVO (View Into Ventricular Onset) is a CE marked software product that was developed to easily determine the location of PVC/VT foci and to reduce procedure time. VIVO improves upon the noninvasive 12 lead ECG by combining the ECG data with an already acquired CT/MRI image and a 3D photo to create a patient specific model, thus improving the localization accuracy.\n\nThe study purpose is to assess the accuracy of VIVO by properly identifying PVC/VT locations and by pacing known sites in the right and left ventricles, and comparing the VIVO predicted location to the current standard mapping system (CARTO).\n\nThe study will enrol 60 patients at 10 centre worldwide. Results will be submitted to US FDA.\n\nPatients scheduled for a PVC or VT ablation procedure will be invited to take part in the study. Subjects will undergo an MRI or CT scan prior to the procedure, which will be used to create a personalised 3D model. This will be merged with a 3D photo of the ECG electrodes on their torso that will be taken at the start of their ablation procedure. During the procedure, in addition to the standard mapping done usually, pace mapping will be done at up to 13 known locations. The ECG data from these locations will be imported into the VIVO software to see if VIVO correctly identified the locations. Patients will receive usual standard clinical care prior to, during and after their scheduled procedure.
REC name
Wales REC 5
REC reference
18/WA/0247
Date of REC Opinion
9 Aug 2018
REC opinion
Further Information Favourable Opinion