Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-04 @ 10:34 PM
Study NCT ID:
NCT03044951
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy endpoint (time to first documented clinical recurrence after blanking period)', 'timeFrame': 'one year', 'description': 'the time to first documented clinical recurrence after blanking period (month)'}, {'measure': 'Safety endpoint (Any procedure-related complications)', 'timeFrame': 'one year', 'description': 'Any procedure-related complications'}], 'secondaryOutcomes': [{'measure': 'Procedure time (min)', 'timeFrame': 'one year', 'description': 'skin to skin'}, {'measure': 'Left atrial time (min)', 'timeFrame': 'one year'}, {'measure': 'X-ray time (min)', 'timeFrame': 'one year'}, {'measure': 'time to first time cardiovascular hospitalization (month)', 'timeFrame': 'one year'}, {'measure': 'QoL changes at 12 months (Units on a Scale)', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'cryoablation', 'irrigated radiofrequency ablation', 'pulmonary vein isolation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '27042964', 'type': 'RESULT', 'citation': 'Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.'}, {'pmid': '24446022', 'type': 'RESULT', 'citation': 'Andrade JG, Khairy P, Macle L, Packer DL, Lehmann JW, Holcomb RG, Ruskin JN, Dubuc M. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):69-75. doi: 10.1161/CIRCEP.113.000586. Epub 2014 Jan 19.'}]}, 'descriptionModule': {'briefSummary': "It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.", 'detailedDescription': 'The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECG recording of atrial fibrillation\n* first time of ablation\n* refractory to at least one anti-arrhythmia drug\n* sign informed consent for participation in the study\n\nExclusion Criteria:\n\n* had ablation before\n* serious heart failure\n* left atrial diameter\\>55mm\n* Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation\n* Stroke in 6 months before the ablation\n* Endocardial thrombosis'}, 'identificationModule': {'nctId': 'NCT03044951', 'acronym': 'CRYO-AF', 'briefTitle': 'Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'DLY201604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cryoballoon ablation', 'description': 'patients who accept cryoballoon ablation', 'interventionNames': ['Procedure: cryoballoon ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'radiofrequency ablation', 'description': 'patients who accept radiofrequency ablation', 'interventionNames': ['Procedure: radiofrequency ablation']}], 'interventions': [{'name': 'cryoballoon ablation', 'type': 'PROCEDURE', 'description': 'cryoballoon ablation：pulmonary vein isolation by cryoballoon', 'armGroupLabels': ['cryoballoon ablation']}, {'name': 'radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'radiofrequency ablation: pulmonary vein isolation by radiofrequency energy', 'armGroupLabels': ['radiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li-Qun Wu', 'role': 'CONTACT', 'email': 'wuliqun89@hotmail.com'}, {'name': 'Tian-You Ling', 'role': 'CONTACT', 'email': 'lty0919@hotmail.com'}], 'facility': 'Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qi Jin', 'role': 'CONTACT', 'email': 'jinqi127@163.com'}], 'overallOfficials': [{'name': 'Li-Qun Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Qi Jin', 'investigatorAffiliation': 'Ruijin Hospital'}}}}