Cardiac ArrhythmiasNCT05450302
Assessing the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection
An observational study of Cardiac Arrhythmias, run by Kansas City Heart Rhythm Research Foundation at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- PURE EP (Observational Study)
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients (male + Female) with age > 18 years from January 2022 till June 2022 will be included in the study.
Who cannot join
- All patients in which PURE EP was not used from January 2022 till June 2022.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Donita Atkins, 913-449-1297, Donita.Atkins@hcahealthcare.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Being tested
- PURE EP (Observational Study)
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURE EP (Observational Study)Other
This is an observational study. No interventions involved in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: PURE EP (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1/1/2022 - 6/30/2022
Sensitivity and specificity
Percen of sensitivity and specificity of predicting a small physiologic signal distinctive from noise
Measured: 1/1/2022 - 6/30/2022
Secondary outcomes (2)
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.
Measured: 1/1/2022 - 6/30/2022
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.
Measured: 1/1/2022 - 6/30/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study startApr 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450302
- Sponsor's protocol ID
- KCHRRF-PURE EP-0011
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32494447Al-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.
PubMed 34554634
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection
- ClinicalTrials.gov ID
- NCT05450302
- Acronym / sponsor ID
- KCHRRF-PURE EP-0011
- Conditions
- Cardiac Arrhythmias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PURE EP | – | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients (male + Female) with age > 18 years from January 2022 till June 2022 will be included in the study.
Key exclusion criteria (1 listed)
- All patients in which PURE EP was not used from January 2022 till June 2022.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PURE EP (Observational Study)This is an observational study. No interventions involved in this study. | Other | PURE EP |
Primary outcome
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.
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
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
2 secondary outcomes
Bipolar amplitude
Time frame: 1/1/2022 - 6/30/2022
Channel of the Bipolar
Time frame: 1/1/2022 - 6/30/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 32494447Padmanabhan 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.
- Background: PubMed 34554634Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanunjaya Lakkireddy principal investigator
Kansas City Heart Rhythm Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Kansas City Heart Rhythm Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (816-651-1969, Datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of High Frequency Algorithm - for signals under 0.3mV distinctive of noise (time frame: 1/1/2022 - 6/30/2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450302, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.