Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05477602
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2022-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'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': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician feedback on algorithm performance', 'timeFrame': 'One day - day of procedure', 'description': 'Data collected during the study will be used to test a signal complexity visualization algorithm evaluated as the technical success of the CathVision ECGenius System to collect and record intracardiac signals during ablation procedures for the treatment of persistent atrial fibrillation.'}], 'secondaryOutcomes': [{'measure': 'Measurement of AF Cycle Length', 'timeFrame': 'One day - day of procedure', 'description': 'Data collected during the study will be used to test an AF cycle length algorithm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electrophysiology', 'cardiac ablation', 'persistent atrial fibrillation', 'cycle length'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.', 'detailedDescription': 'A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.\n\nSubjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.\n\nThe validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients indicated for a cardiac ablation for the treatment of persistent atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.\n* Male or non-pregnant female aged ≥ 21 years.\n* Able and willing to provide written informed consent prior to any clinical investigation related procedure.\n\nExclusion Criteria:\n\n* Current participation in another investigational drug or device study that interferes with this study.\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n* Life expectancy less than 12 month, in the opinion of the Investigator.\n* Subjects who, in the opinion of the investigator, are not candidates for this study.\n* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population."}, 'identificationModule': {'nctId': 'NCT05477602', 'briefTitle': 'The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System', 'organization': {'class': 'INDUSTRY', 'fullName': 'CathVision ApS'}, 'officialTitle': 'The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)', 'orgStudyIdInfo': {'id': 'CathVision'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac Ablation for the treatment of persistent Atrial Fibrillation', 'type': 'PROCEDURE', 'otherNames': ['Persistent AF Ablation'], 'description': 'Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CathVision ApS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}