Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-12 @ 12:57 AM
Study NCT ID:
NCT03091205
Status:
WITHDRAWN
Last Update Posted:
2018-05-30
First Post:
2017-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proper Extent of Maze Intercaval Lesion
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unable to obtain funding source', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-25', 'studyFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance until complete loss of conductive tissue', 'timeFrame': '6 Months', 'description': 'To measure the mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "It's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible could be entered into the study if they meet the inclusion/exclusion requirements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years male or female\n* Scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible\n* Subjects willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Subjects receiving surgery with non-sternotomy access\n* Presence of or history of transvenous pacing leads\n* Subjects receiving a re-do cardiac surgery\n* Subjects with a history of pericarditis\n* Subjects who are in atrial fibrillation or atrial flutter and cannot be converted out of it.\n* Any medical condition or finding for which the Investigator used medical discretion to determine the subject should be excluded\n* Subject is currently participating in another clinical trial.\n* Subject is unable to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT03091205', 'acronym': 'Maze', 'briefTitle': 'Proper Extent of Maze Intercaval Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Proper Extent of Maze Intercaval Lesion', 'orgStudyIdInfo': {'id': '017-048'}}, 'contactsLocationsModule': {'locations': [{'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Timothy George, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Reasearch Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}