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

Cardiac Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05450302
• Other study ID #: KCHRRF-PURE EP-0011
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: December 2023

Study information

• Verified date: June 2022
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: Datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Other:
• PURE EP (Observational Study)
This is an observational study. No interventions involved in this study.

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Al-Ahmad A, Knight B, Tzou W, Schaller R, Yasin O, Padmanabhan D, Zagrodzky J, Bassiouny M, Burkhardt JD, Gallinghouse GJ, Mansour M, McLeod C, Natale A. Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study. J Cardiovasc Electrophysiol. 2021 Nov;32(11):2915-2922. doi: 10.1111/jce.15250. Epub 2021 Oct 1. — View Citation

Padmanabhan D, Foxall T, Drakulic B, Witt C, Killu A, Naksuk N, Sugrue A, Venkatachalam KL, Asirvatham S. Initial Experience with the BioSig PURE EP Signal Recording System: An Animal Laboratory Experience. J Innov Card Rhythm Manag. 2017 Apr 15;8(4):2690-2699. doi: 10.19102/icrm.2017.080407. eCollection 2017 Apr. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Sensitivity and specificity	Percen of sensitivity and specificity of predicting a small physiologic signal distinctive from noise	1/1/2022 - 6/30/2022
Secondary	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
Secondary	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