NCT05450302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 10, 2023

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

June 30, 2022

Last Update Submit

March 8, 2023

Conditions

Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Sensitivity and specificity

    Percen of sensitivity and specificity of predicting a small physiologic signal distinctive from noise

    1/1/2022 - 6/30/2022

Secondary Outcomes (2)

  • Bipolar amplitude

    1/1/2022 - 6/30/2022

  • Channel of the Bipolar

    1/1/2022 - 6/30/2022

Study Arms (1)

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)

Interventions

PURE EP (Observational Study)OTHER

This is an observational study. No interventions involved in this study.

PURE EP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All patients (male + Female) with age \> 18 years from January 2022 till June 2022 will be included in the study.

You may not qualify if:

  • All patients in which PURE EP was not used from January 2022 till June 2022.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Related Publications (2)

  • 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.

    PMID: 32494447BACKGROUND

  • 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.

    PMID: 34554634BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Dhanunjaya Lakkireddy

    Kansas City Heart Rhythm Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969Datkins@kchrf.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 8, 2022

Study Start

April 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

March 10, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)