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A multi-center study designed to assess the accuracy of VIVOâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All patients will undergo standard of care ablation procedures. VIVOâ„¢ results will be compared to that of standard of care results, but will not be used in diagnosis or treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVOâ„¢ | Device | Diagnose the area of a PVC or VT onset |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Missiaen Huck | Catheter Precision. Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Johns Hopkins Unveristy |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 23, 2020 | Aug 6, 2020 | 3 | ||
| Jul 16, 2025 |
| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Medical Unversity of South Carolina | Charleston | South Carolina | 29425 | United States |
| Aug 1, 2025 |
| 4 |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |