Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT05492760
Status:
UNKNOWN
Last Update Posted:
2022-08-09
First Post:
2022-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation
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': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-06', 'studyFirstSubmitDate': '2022-07-31', 'studyFirstSubmitQcDate': '2022-08-06', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the time to atrial fibrillation recurrent', 'timeFrame': '1year after the cryoballoon ablation', 'description': 'the time to atrial fibrillation recurrent'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF recurrence. The characters of ablation procedure is also of critical importance to durable clinical success such as temperature features and time-to-isolation (TTI). The aim of our study is to develop an tool of recurrence risk evaluation with both pre-procedure and procedure factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with paroxysmal AF and accept cryoballoon ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with paroxysmal AF and accept cryoballoon ablation.\n\nExclusion Criteria:\n\n* left atrium (LA) diameter (anterior-to-posterior)\\>55mm on transthoracic echocardiography (TTE)\n* the presence of thrombus in the LA or left atrial appendage (LAA) on transesophageal echocardiography (TEE)\n* uncorrected heart failure (NYHA class III or IV),\n* concomitant moderate or severe valvular heart disease or bioprosthetic valve,\n* malignancy necessitating chemotherapy.'}, 'identificationModule': {'nctId': 'NCT05492760', 'acronym': 'era-cryo', 'briefTitle': 'Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation： a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'era-cryo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ablation group', 'interventionNames': ['Device: cryoballoon ablation']}], 'interventions': [{'name': 'cryoballoon ablation', 'type': 'DEVICE', 'description': 'Patients with AF will accept cryoballoon ablation.', 'armGroupLabels': ['ablation group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yawei Xu, doctor', 'role': 'CONTACT', 'email': 'xuyawei@tongji.edu.cn', 'phone': '13916698181'}], 'overallOfficials': [{'name': 'Yawei Xu, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ya-Wei Xu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}