Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-06 @ 1:00 AM
Study NCT ID:
NCT01812356
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2013-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-29', 'releaseDate': '2019-10-07'}], 'estimatedResultsFirstSubmitDate': '2019-10-07'}}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2013-03-08', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence of atrial fibrillation', 'timeFrame': 'one year', 'description': 'Treatment failure'}], 'secondaryOutcomes': [{'measure': 'Postoperative stroke', 'timeFrame': 'one year', 'description': 'Thromboembolism'}, {'measure': 'Atrial arrhythmia events', 'timeFrame': 'one year', 'description': 'AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion'}, {'measure': 'Cardiac related death', 'timeFrame': 'one year', 'description': 'Including sudden death'}, {'measure': 'heart failure', 'timeFrame': 'one year', 'description': 'heart failure requiring admission'}, {'measure': 'Reoperation', 'timeFrame': 'one year', 'description': 'reoperation due to heart problems'}, {'measure': 'Intracranial hemorrhage', 'timeFrame': 'one year', 'description': 'bleeding complication involving brain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'maze operation', 'cryoablation'], 'conditions': ['Atrial Fibrillation', 'Valve']}, 'descriptionModule': {'briefSummary': 'The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.\n\nThe investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.', 'detailedDescription': 'The investigators have used the Medtronic ATS cryoprobe (Argon based) since 2009 for cryomaze procedure for treatment of atrial fibrillation combined with valvular heart disease.\n\nHowever, sometimes, it was inconvenient due to excess flexibility, wide lesion related to excess low temperature and time-consuming detachment from atrium after cryoablation. The investigators introduced Atricure cryoprobe (Nitreos Oxide based) in hope of overcoming these shortcomings of ATS probes last year.\n\nUp to date, the investigators have been satisfactory in terms of the surgical convenience. On the other hand, we have the questionability of transmural lesion of Atricure probe because of the higher temperature of Atricure probe compared with ATS probe.\n\nThe aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.\n\nThe investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)\n* between 18 and 75 years old\n\nExclusion Criteria:\n\n* previous cardiac surgery\n* Behcet disease\n* Takayasu's arteritis\n* Infective endocarditis\n* Congenital heart disease\n* left atrial size over 80mm\n* moderate or greater functional tricuspid regurgitation"}, 'identificationModule': {'nctId': 'NCT01812356', 'briefTitle': 'The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas', 'orgStudyIdInfo': {'id': '2012-11-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Argon gas probe', 'description': 'Cryomaze procedure using Argon gas probe', 'interventionNames': ['Device: Cryomaze procedure using Argon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrous oxide probe', 'description': 'Cryomaze procedure using Nitrous oxide probe', 'interventionNames': ['Device: Cryomaze procedure using Nitrous oxide']}], 'interventions': [{'name': 'Cryomaze procedure using Nitrous oxide', 'type': 'DEVICE', 'otherNames': ['Atricure cryoprobe'], 'description': 'Cryomaze procedure using Nitrous oxide', 'armGroupLabels': ['Nitrous oxide probe']}, {'name': 'Cryomaze procedure using Argon', 'type': 'DEVICE', 'otherNames': ['ATS medtronic probe'], 'description': 'Cryomaze procedure using Argon', 'armGroupLabels': ['Argon gas probe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pyo Won Park, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-10-07', 'type': 'RELEASE'}, {'date': '2019-10-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Samsung Medical Center'}}}}