Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-27 @ 3:17 AM
Study NCT ID:
NCT05301803
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kpf@cathvision.com', 'phone': '+4531324745', 'title': 'Clinical Research Manager', 'organization': 'CathVision ApS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'from hospital admission to discharge, typically one day.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': 'Consecutive patients referred for an electrophysiology study or cardiac ablation.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pericardial effusion', 'notes': 'pericardial effusion after transeptal puncture requiring pericardial drainage.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline Noise Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Consecutive patients referred for an electrophysiology study or cardiac ablation.'}], 'classes': [{'title': 'ECGenius Bipolar Baseline Noise', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '29'}]}]}, {'title': 'ECGenius Unipolar Baseline Noise', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '126'}]}]}, {'title': 'LabSystem Pro Bipolar Baseline Noise', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '38'}]}]}, {'title': 'LabSystem Pro Unipolar Noise', 'categories': [{'measurements': [{'value': '463', 'groupId': 'OG000', 'lowerLimit': '138', 'upperLimit': '525'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'EP and ablation procedures can take up to six hours', 'description': 'Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV', 'unitOfMeasure': 'μV', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline noise'}, {'type': 'PRIMARY', 'title': 'Freedom From Major Adverse Events, Evaluated at Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Consecutive patients referred for an electrophysiology study or cardiac ablation.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From EP procedure to discharge is usually one day.', 'description': 'Freedom from major adverse events, evaluated at hospital discharge\n\nAdverse events were categorized as one of:\n\nAn adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device.\n\nA Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE.\n\nAn unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm', 'description': 'Consecutive patients referred for an electrophysiology study or cardiac ablation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'Consecutive patients referred for an electrophysiology study or cardiac ablation.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.67', 'spread': '7.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-09', 'size': 515171, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-08T06:38', 'hasProtocol': True}, {'date': '2023-03-27', 'size': 341717, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-08T06:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2022-03-21', 'resultsFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-28', 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Noise Comparison', 'timeFrame': 'EP and ablation procedures can take up to six hours', 'description': 'Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV'}, {'measure': 'Freedom From Major Adverse Events, Evaluated at Hospital Discharge', 'timeFrame': 'From EP procedure to discharge is usually one day.', 'description': 'Freedom from major adverse events, evaluated at hospital discharge\n\nAdverse events were categorized as one of:\n\nAn adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device.\n\nA Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE.\n\nAn unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electrophysiology', 'atrial fibrillation', 'cardiac ablation'], 'conditions': ['Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.', 'detailedDescription': 'A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system.\n\nPatients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision ECGenius® System in parallel with a commercial EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients indicated for EP study or cardiac ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.\n* At least 18 years of age.\n* Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).\n\nExclusion Criteria:\n\n* Patient inability to understand or refusal to sign informed consent.\n* Patient is a prisoner or under incarceration\n* Patients who in the opinion of the physician are not candidates for this study.'}, 'identificationModule': {'nctId': 'NCT05301803', 'briefTitle': 'An Evaluation of the Safety and Performance of the CathVision ECGenius® System.', 'organization': {'class': 'INDUSTRY', 'fullName': 'CathVision ApS'}, 'officialTitle': 'A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical Performance of the CathVision ECGenius® System.', 'orgStudyIdInfo': {'id': 'CP-00003-A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Electrophysiology procedure', 'type': 'DEVICE', 'description': 'Electrophysiology testing and cardiac ablation of arrhythmia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The University of vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Nathaniel C Thompson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Vermont Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CathVision ApS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medicept Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}