Cardiac Arrhythmias
Conditions
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.
Interventions
OTHERPURE EP (Observational Study)
This is an observational study. No interventions involved in this study.
Sponsors
Kansas City Heart Rhythm Research Foundation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive value of High Frequency Algorithm - for signals under 0.3mV distinctive of noise | 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 | 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 |
| Sensitivity and specificity | 1/1/2022 - 6/30/2022 | Percen of sensitivity and specificity of predicting a small physiologic signal distinctive from noise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bipolar amplitude | 1/1/2022 - 6/30/2022 | 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. |
| Channel of the Bipolar | 1/1/2022 - 6/30/2022 | 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. |
Countries
United States
Contacts
Primary ContactDonita Atkins
Outcome results
None listed