Assessing the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection

Study Overview
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Brief Summary
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Prior multicenter study demonstrated superiority of PURE EP to conventional mapping. This superiority was seen when comparing small, fractionated signals of interest, near-field vs far-field distinction, and general signal quality (2). Hence, investigators propose a retrospective study to assess the predictive value of high frequency algorithm (HFA) for identifying local physiologic signal under 0.3 mV distinctive of noise.

Detailed Description
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Accurate interpretation of intracardiac EGMs remains essential to the field of electrophysiology (EP). Conventional Electro-anatomical mapping systems (EAMs) have made significant improvements in EGM quality and noise reduction since their emergence, however their use of variable gain amplifiers and high/low pass filters, often provide visualization of low amplitude signals that lead to saturation artifact or necessitate signal clipping. PURE EPTM (BioSig Technologies, Inc., Westport, CT, USA), in contrast does provide the ability to record this unaltered signal with more customizable display options. Their proprietary amplifier and high-resolution analog-digital converters with Radiofrequency (RF) suppression eliminates the need for gain switching, optimizing resolution of the full range of input signals (1). Prior multicenter study demonstrated superiority of PURE EP to conventional mapping. This superiority was seen when comparing small, fractionated signals of interest, near-field vs far-field distinction, and general signal quality (2). Hence, investigators propose a retrospective study to assess the predictive value of high frequency algorithm (HFA) for identifying local physiologic signal under 0.3 mV distinctive of noise.

Official Title
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To Assess the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection

Conditions
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Cardiac Arrhythmias

Intervention / Treatment
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* Other: PURE EP (Observational Study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients (male + Female) with age > 18 years from January 2022 till June 2022 will be included in the study. Exclusion Criteria: All patients in which PURE EP was not used from January 2022 till June 2022.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PURE EP<br>All patients from January 2022 till June 2022 in whom PURE EP was used at the Kansas City Heart Rhythm Institute, Overland Park, Kansas | Other: PURE EP (Observational Study)<br>* This is an observational study. No interventions involved in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of High Frequency Algorithm - for signals under 0.3mV distinctive of noise | Validate the predictive value of High Frequency Algorithm (HFA) for identifying local physiologic signals under 0.3mV distinctive of noise. | 1/1/2022 - 6/30/2022 | 
| Predictive value of High Frequency Algorithm - for signals under 0.1mV distinctive of noise | Validate the predictive value of High Frequency Algorithm (HFA) for identifying local physiologic signals under 0.1mV distinctive of noise | 1/1/2022 - 6/30/2022 | 
| Sensitivity and specificity | Percen of sensitivity and specificity of predicting a small physiologic signal distinctive from noise | 1/1/2022 - 6/30/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bipolar amplitude | The measurement tool, specifically within PURE EP, called Horizontal Caliper Mode similar to that of recording and mapping systems, will measure the millivolt peak-to-peak amplitude of the bipolar signal, which is identified by its electrode numbers. | 1/1/2022 - 6/30/2022 | 
| Channel of the Bipolar | It depends on which channel has the low amplitude signal and it may change based on the signal. It is measured by Horizontal Caliper Mode '' in millivolts in the PURE EP program. | 1/1/2022 - 6/30/2022 |