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The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking algorithms within the Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1
The secondary objective is to evaluate catheter rendering in the VRP system.
This is an acute, multi-center, observational, prospective feasibility study with up to 80 patients at up to 5 centers in Europe.
Data will be simultaneously collected on both the EnSite Precision 2.0.1 and VRP mapping systems for the entire duration of the EP mapping and ablation procedure. This study will not require significant change to the current clinical workflow of the mapping and ablation procedure. The VRP operator will observe both displays in real-time and will enter extensive electronic annotations to the VRP data stream to facilitate retrospective analysis. Examples of annotations include drug administration, patient movement, and the introduction of devices such as an intracardiac Echography (ICE) catheter which are not visible on the EnSite mapping system.
If/when the VRP operator notices events which might be better understood with additional data, he/she might ask the physician to hold a catheter in a stable position for an extra few seconds and/or move the catheter to another position. Examples of such events include catheters appearing outside the 3D model and unrealistic catheter shapes on either display. Compliance with such requests is optional and subject to physician preference.
Retrospective data analysis will focus on characterization of the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnSite Precision | Device | Ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate feasibility of new algorithms witihn the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1. | Demonstrate feasibility of new algorithms within the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1 | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient undergoing a cardiac EP mapping and ablation procedure in which a SJM sensor-enabled catheter and the EnSite Precision Cardiac Mapping system is used, is considered eligible for enrollment.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2024 | |
| Reset | Nov 19, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2024 | Nov 19, 2024 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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