Clinical trial NCT03110146: EnSite Precision 2.1 Feasibility Study
Official title: EnSite Precision 2.1 Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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:

* Occurence rates and potential causes for Shift and Drift.
* Frequency and severity of discrepancies between impedance and magnetic coordinates.
* Positions of catheters relative to the 3D model.
* Positions of catheters relative to each other, comparing to fluoroscopic images when available.
* Shapes of catheters on the research system as the catheters are moved to different locations.
* Final geometry apprearance on the VRP.
* Voltage and timing maps appearance on the VRP.

Eligibility criteria: Inclusion Criteria:

* Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system.
* Over 18 years of age
* Ability to provide informed consent for study participation and be willing and able to comply with the protocol described evaluations.

Exclusion Criteria:

* Pregnant or possibly pregnant patients

Primary outcomes:
measure: 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.
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
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Study officials:
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