Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT01165593
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2010-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2010-07-16', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LA size measurements', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to gather information about the size and shape of patients' hearts in order to design a device.", 'detailedDescription': 'Correct device design depends on getting good information about the shape and size of the different parts of the heart. Measurements from computed tomography images of hearts will be studied. By looking at measurements from a wide range of patients, an understanding of the differences in the size and shape of the heart chambers will be gained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atrial fibrillation who are deemed suitable for treatment of atrial fibrillation by catheter-based ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients deemed suitable for treatment of atrial fibrillation by catheter-based ablation who have received cardiac CT imaging as part of normal care.\n\nExclusion Criteria:\n\n* Patients who have not received cardiac CT imaging as part or normal care.'}, 'identificationModule': {'nctId': 'NCT01165593', 'briefTitle': 'Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kardium Inc.'}, 'officialTitle': 'Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases', 'orgStudyIdInfo': {'id': 'H10-01337'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with atrial fibrillation', 'description': 'Patients with atrial fibrillation who have received a cardiac CT scan as part of normal care prior to catheter-based treatment of atrial fibrillation.', 'interventionNames': ['Other: There is no intervention that is a part of this study.']}], 'interventions': [{'name': 'There is no intervention that is a part of this study.', 'type': 'OTHER', 'description': 'There is no intervention that is a part of this study. Imaging data is gathered as part of normal care.', 'armGroupLabels': ['Patients with atrial fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'John A. Yeung-Lai-Wah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St' Paul's Hospital Electrophysiology (Providence Health Care)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kardium Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "St. Paul's Hospital, Canada", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}