Assessing the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection
- Conditions
- Cardiac Arrhythmias
- Interventions
- Other: PURE EP (Observational Study)
- Registration Number
- NCT05450302
- Lead Sponsor
- Kansas City Heart Rhythm Research Foundation
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
All patients (male + Female) with age > 18 years from January 2022 till June 2022 will be included in the study.
All patients in which PURE EP was not used from January 2022 till June 2022.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PURE EP PURE EP (Observational Study) All patients from January 2022 till June 2022 in whom PURE EP was used at the Kansas City Heart Rhythm Institute, Overland Park, Kansas
- Primary Outcome Measures
Name Time Method 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.
Sensitivity and specificity 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 0.1mV 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
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Kansas City Heart Rhythm Institute
🇺🇸Overland Park, Kansas, United States