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

March 8, 2023 updated by: Kansas City Heart Rhythm Research Foundation

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PURE EP
All patients from January 2022 till June 2022 in whom PURE EP was used at the Kansas City Heart Rhythm Institute, Overland Park, Kansas
Other: PURE EP (Observational Study)
This is an observational study. No interventions involved in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1/1/2022 - 6/30/2022
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
1/1/2022 - 6/30/2022
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
1/1/2022 - 6/30/2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bipolar amplitude
Time Frame: 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.
1/1/2022 - 6/30/2022
Channel of the Bipolar
Time Frame: 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.
1/1/2022 - 6/30/2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRRF-PURE EP-0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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