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

Kansas City Heart Rhythm Research Foundation

Status: Not yet enrolling

Conditions: Cardiac Arrhythmias

Treatments: Other: PURE EP (Observational Study)

Study type: Observational

Funder types: Other

Identifiers

NCT05450302

KCHRRF-PURE EP-0011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

PURE EP

Description:

All patients from January 2022 till June 2022 in whom PURE EP was used at the Kansas City Heart Rhythm Institute, Overland Park, Kansas

Treatment:

Other: PURE EP (Observational Study)