Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT05450302
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2022-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-07-06', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive value of High Frequency Algorithm - for signals under 0.3mV distinctive of noise', 'timeFrame': '1/1/2022 - 6/30/2022', 'description': 'Validate the predictive value of High Frequency Algorithm (HFA) for identifying local physiologic signals under 0.3mV distinctive of noise.'}, {'measure': 'Predictive value of High Frequency Algorithm - for signals under 0.1mV distinctive of noise', 'timeFrame': '1/1/2022 - 6/30/2022', 'description': 'Validate the predictive value of High Frequency Algorithm (HFA) for identifying local physiologic signals under 0.1mV distinctive of noise'}, {'measure': 'Sensitivity and specificity', 'timeFrame': '1/1/2022 - 6/30/2022', 'description': 'Percen of sensitivity and specificity of predicting a small physiologic signal distinctive from noise'}], 'secondaryOutcomes': [{'measure': 'Bipolar amplitude', 'timeFrame': '1/1/2022 - 6/30/2022', 'description': '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.'}, {'measure': 'Channel of the Bipolar', 'timeFrame': '1/1/2022 - 6/30/2022', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrhythmias']}, 'referencesModule': {'references': [{'pmid': '32494447', 'type': 'BACKGROUND', '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.'}, {'pmid': '34554634', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPURE 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).\n\nPrior 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients (male + Female) with age \\> 18 years from January 2022 till June 2022 will be included in the study.\n\nExclusion Criteria:\n\nAll patients in which PURE EP was not used from January 2022 till June 2022.'}, 'identificationModule': {'nctId': 'NCT05450302', 'briefTitle': 'Assessing the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection', 'organization': {'class': 'OTHER', 'fullName': 'Kansas City Heart Rhythm Research Foundation'}, 'officialTitle': 'To Assess the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection', 'orgStudyIdInfo': {'id': 'KCHRRF-PURE EP-0011'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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', 'interventionNames': ['Other: PURE EP (Observational Study)']}], 'interventions': [{'name': 'PURE EP (Observational Study)', 'type': 'OTHER', 'description': 'This is an observational study. No interventions involved in this study.', 'armGroupLabels': ['PURE EP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'Donita.Atkins@hcahealthcare.com', 'phone': '913-449-1297'}], 'facility': 'Kansas City Heart Rhythm Institute', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'centralContacts': [{'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'Datkins@kchrf.com', 'phone': '816-651-1969'}], 'overallOfficials': [{'name': 'Dhanunjaya Lakkireddy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas City Heart Rhythm Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas City Heart Rhythm Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}