To Assess the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Sensitivity and specificity
Time Frame: 1/1/2022 - 6/30/2022
Percen of sensitivity and specificity of predicting a small physiologic signal distinctive from noise
Predictive value of High Frequency Algorithm - for signals under 0.3mV distinctive of noise
Time Frame: 1/1/2022 - 6/30/2022
Validate the predictive value of High Frequency Algorithm (HFA) for identifying local physiologic signals under 0.3mV distinctive of noise.
Predictive value of High Frequency Algorithm - for signals under 0.1mV distinctive of noise
Time Frame: 1/1/2022 - 6/30/2022
Validate the predictive value of High Frequency Algorithm (HFA) for identifying local physiologic signals under 0.1mV distinctive of noise
Secondary Outcomes
- Channel of the Bipolar(1/1/2022 - 6/30/2022)
- Bipolar amplitude(1/1/2022 - 6/30/2022)