VIVO™ Accuracy Study

VIVO™ Accuracy Study

A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.

The VIVO accuracy study will assess the accuracy of locating a PVC/VT foci by pacing known anatomical locations and comparing the VIVO outcome to that of the Carto system (Biosense-Webster).

Inclusion Criteria:

• Subjects who are at least 18 years or older
• Subjects who are scheduled for PVC/VT ablation procedure with structurally normal hearts and less than 10% scar.
• Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
• Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)

Exclusion Criteria:

• Subjects who are contraindicated for CT or MRI (must be able to get one)
• Subject whose MRI or CT scan does not comply with the requirements of this protocol
• Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:
• INR > 3
• Active infection
• Pregnancy: Females of childbearing potential with a positive pregnancy test.
• Existing mechanical heart valve