Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00584558
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2007-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-Term Follow-Up of Patients Undergoing Catheter Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karen-beckman@ouhsc.edu', 'phone': '405-271-9696', 'title': 'Karen Beckman, MD', 'phoneExt': '37536', 'organization': 'University of Oklahoma Health Sciences Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Observational Arm', 'description': 'Patients undergoing catheter ablation.\n\nCatheter Ablation: Catheter Ablation of arrhythmias', 'otherNumAtRisk': 2420, 'deathsNumAtRisk': 2420, 'otherNumAffected': 24, 'seriousNumAtRisk': 2420, 'deathsNumAffected': 6, 'seriousNumAffected': 72}], 'otherEvents': [{'term': 'IVC thrombus', 'notes': 'IVC thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2420, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac Tamponade', 'notes': 'Cardiac Tamponade 3%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2420, 'numEvents': 72, 'numAffected': 72}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Arrhythmia Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2420', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1-Catheter Ablation', 'description': 'There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-10 years', 'description': 'Number and % patients with documented arrhythmias recurrences', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who underwent ablation of arrhythmias'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Complications From Catheter Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2430', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1-Observational', 'description': 'There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-10 years', 'description': 'Number and % of patients with major adverse events as recorded in the medical record', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1-Catheter Ablation', 'description': 'There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2420'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2420'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2420', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Observational Arm', 'description': 'All patients studied'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '678', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1306', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '436', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '992', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1428', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2420', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-03', 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Arrhythmia Recurrence', 'timeFrame': '0-10 years', 'description': 'Number and % patients with documented arrhythmias recurrences'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Complications From Catheter Ablation', 'timeFrame': '0-10 years', 'description': 'Number and % of patients with major adverse events as recorded in the medical record'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arrhythmia', 'Catheter Ablation'], 'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at the OU Medical Center.', 'detailedDescription': 'The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at this institution, including recurrence of the ablated arrhythmia and any late complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing catheter ablation at the OU Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing catheter ablation at the OU Medical Center\n\nExclusion Criteria:\n\n* Prisoners\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT00584558', 'briefTitle': 'Long-Term Follow-Up of Patients Undergoing Catheter Ablation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Long-Term Follow-Up of Catheter Ablation', 'orgStudyIdInfo': {'id': '1239'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients undergoing catheter ablation.', 'interventionNames': ['Procedure: Catheter Ablation']}], 'interventions': [{'name': 'Catheter Ablation', 'type': 'PROCEDURE', 'otherNames': ['All approved ablation catheters', 'Investigational ablation catheters'], 'description': 'Catheter Ablation of arrhythmias', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OU Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Karen Beckman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karen Beckman, MD', 'investigatorAffiliation': 'University of Oklahoma'}}}}