Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT03998956
Status:
UNKNOWN
Last Update Posted:
2019-07-01
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-density Mapping-guided bOx Isolation and subsTrate Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D064752', 'term': 'Atrial Remodeling'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-28', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sinus rhythm maintenance rate', 'timeFrame': '12 months', 'description': 'Holter is performed 12months after the procedure and heart rhythm is recorded.'}], 'secondaryOutcomes': [{'measure': 'left ventricular ejection fraction', 'timeFrame': '12 months', 'description': 'LVEF is evaluated by echocardiography 12months after the procedure.'}, {'measure': 'Stroke or embolic events', 'timeFrame': '12 months', 'description': 'History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.'}, {'measure': 'Atrial fibrosis', 'timeFrame': '1 day', 'description': 'Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['catheter ablation'], 'conditions': ['Atrial Fibrillation', 'Atrial Remodeling']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed.\n* Age of 18 to 75 years old.\n* Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.\n* Willing to have catheter ablation for atrial fibrillation.\n\nExclusion Criteria:\n\n* Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.\n* Complete atrioventricular block.\n* An acute stroke or contradiction of anti-coagulation.\n* Hyperthyroidism.\n* Having a history of catheter ablation of atrial fibrillation.\n* Left atrial appendage thrombosis confirmed by transesophageal echocardiography.\n* Pregnancy or lactation.\n* Planning for pregnancy in the near future.\n* Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.\n* Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.'}, 'identificationModule': {'nctId': 'NCT03998956', 'acronym': 'HOT', 'briefTitle': 'High-density Mapping-guided bOx Isolation and subsTrate Ablation', 'organization': {'class': 'OTHER', 'fullName': 'The Third Xiangya Hospital of Central South University'}, 'officialTitle': 'Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': '3rdxiangya@csu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Circumferential PV isolation', 'description': 'Circumferential PV isolation only', 'interventionNames': ['Procedure: CPVI']}, {'type': 'EXPERIMENTAL', 'label': 'Circumferential PV and BOX isolation', 'description': 'Circumferential PV and BOX isolation', 'interventionNames': ['Procedure: CPVI+BOX']}, {'type': 'EXPERIMENTAL', 'label': 'circumferential PV and BOX isolation with substrate ablation', 'description': 'Atrial substrate ablation apart from circumferential PV and BOX isolation', 'interventionNames': ['Procedure: CPVI+BOX+SUB']}], 'interventions': [{'name': 'CPVI', 'type': 'PROCEDURE', 'description': 'Circumferential PV isolation only', 'armGroupLabels': ['Circumferential PV isolation']}, {'name': 'CPVI+BOX', 'type': 'PROCEDURE', 'description': 'Circumferential PV and BOX isolation', 'armGroupLabels': ['Circumferential PV and BOX isolation']}, {'name': 'CPVI+BOX+SUB', 'type': 'PROCEDURE', 'description': 'Atrial substrate ablation apart from circumferential PV and BOX isolation', 'armGroupLabels': ['circumferential PV and BOX isolation with substrate ablation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}