Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-27 @ 9:26 PM
Study NCT ID:
NCT01920295
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2013-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2013-05-01', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)', 'timeFrame': '12 months from the procedure', 'description': 'At prespecified interval of 12th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring'}, {'measure': 'Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)', 'timeFrame': '3 months from the procedure', 'description': 'At prespecified interval of 3rd month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring'}, {'measure': 'Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)', 'timeFrame': '6 months from the procedure', 'description': 'At prespecified interval of 6th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring'}, {'measure': 'Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)', 'timeFrame': '9 months from the procedure', 'description': 'At prespecified interval of 9th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* paroxysmal atrial fibrillation, symptomatic\n\nExclusion Criteria:\n\n* atrial fibrillation other than PAF, asymptomatic, previous AF ablation'}, 'identificationModule': {'nctId': 'NCT01920295', 'acronym': 'C-frost', 'briefTitle': 'Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Yuksek Ihtisas Hospital'}, 'orgStudyIdInfo': {'id': '3196568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoballoon ablation', 'description': 'Cryoballoon ablation', 'interventionNames': ['Device: Cryoballoon ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cryoballoon after medical therapy', 'description': 'Cryoballoon ablation', 'interventionNames': ['Device: Cryoballoon ablation']}, {'type': 'EXPERIMENTAL', 'label': 'Cryoballoon as first-line therapy', 'description': 'Cryoballoon ablation', 'interventionNames': ['Device: Cryoballoon ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cryoballoon after failed drug therapy', 'description': 'Cryoballoon ablation', 'interventionNames': ['Device: Cryoballoon ablation']}], 'interventions': [{'name': 'Cryoballoon ablation', 'type': 'DEVICE', 'armGroupLabels': ['Cryoballoon ablation', 'Cryoballoon after failed drug therapy', 'Cryoballoon after medical therapy', 'Cryoballoon as first-line therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Yuksek Ihtisas Heart-Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuksek Ihtisas Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Serkan Cay', 'investigatorAffiliation': 'Yuksek Ihtisas Hospital'}}}}