VIVO™ Accuracy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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VIVO™ Accuracy Study

Conditions
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Premature Ventricular Contraction, Ventricular Tachycardia

Intervention / Treatment
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* Device: VIVO™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>All patients will undergo standard of care ablation procedures. VIVO™ results will be compared to that of standard of care results, but will not be used in diagnosis or treatment. | Device: VIVO™<br>* Diagnose the area of a PVC or VT onset<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of correctly identifying PVC or VT origin | Determine the accuracy of VIVO in identifying a PVC/VT to the left or right ventricle or the septum. The origin, identified by VIVO, will be compared to the Carto system and the successful ablation location. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of correctly identifying known pacing sites | Determine the accuracy of VIVO in identifying the location of known pacing sites as compared to the Carto system. The origin, identified by VIVO, will be compared to the location identified by Carto as well as the successful ablation location. | 1 Day | 
| Number of adverse events | Monitor adverse events that occur during the procedure followed by a review from the CEC for correlation to VIVO and adjudication if appropriate. | 1 Day |