Premature Ventricular Contraction, Ventricular Tachycardia
Conditions
Brief summary
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
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).
Interventions
DEVICEVIVO™
Diagnose the area of a PVC or VT onset
Sponsors
Catheter Precision. Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of correctly identifying PVC or VT origin | 1 Day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of correctly identifying known pacing sites | 1 Day | 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. |
| Number of adverse events | 1 Day | Monitor adverse events that occur during the procedure followed by a review from the CEC for correlation to VIVO and adjudication if appropriate. |
Countries
United States
Outcome results
None listed