Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-28 @ 11:56 PM
Study NCT ID:
NCT01935557
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2013-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-13', 'studyFirstSubmitDate': '2013-09-01', 'studyFirstSubmitQcDate': '2013-09-01', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'therapeutic ACT retention rate during procedure', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Continuous heparin infusion', 'Intermittent heparin infusion', 'during catheter ablation'], 'conditions': ['Coagulation; Intravascular']}, 'referencesModule': {'references': [{'pmid': '29766891', 'type': 'DERIVED', 'citation': 'Kim TS, Kim SH, Kim BK, Kim JY, Kim JH, Jang SW, Lee MY, Rho TH, Oh YS. Randomized Comparison of Continuous Versus Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2016 Jun;2(3):319-326. doi: 10.1016/j.jacep.2015.11.004. Epub 2015 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'Optimal anticoagulation using heparin with close attention to maintain therapeutic dosing during the procedure is important.\n\nRandomized comparison of continuous and intermittent heparin infusion during catheter ablation of Atrial Fibrillation.', 'detailedDescription': 'Intravenous heparin was used during the procedure to prevent catheter-induced thrombosis.\n\nheparin is administered during the procedure to achieve recommended activation clotting times (ACT) values, typically \\>300 seconds to prevent thromboemboli during the procedure.\n\nMost of the practitioners was that ACT level should be checked at 30- to 60-minute intervals and then have injected intermittently.\n\nintermittent heparin infusion, concentration is great changed because the heparin has 30minutes half-period.\n\nresearchers postulate that a constant therapeutic concentrations would be beneficial to continuous infusion than intermittent infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Atrial Fibrillation, Radiofrequency catheter ablation scheduled\n\nExclusion Criteria:\n\n* Clinical trial denied'}, 'identificationModule': {'nctId': 'NCT01935557', 'acronym': 'COHERE', 'briefTitle': 'Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'COHERE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous heparin infusion group', 'description': 'continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.', 'interventionNames': ['Drug: Continuous heparin infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent heparin infusion group', 'description': 'Intermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician.', 'interventionNames': ['Drug: Intermittent heparin infusion']}], 'interventions': [{'name': 'Continuous heparin infusion', 'type': 'DRUG', 'description': 'continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.', 'armGroupLabels': ['Continuous heparin infusion group']}, {'name': 'Intermittent heparin infusion', 'type': 'DRUG', 'description': 'Intermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician.', 'armGroupLabels': ['Intermittent heparin infusion group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul st. mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong Seog Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yong Seog Oh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yong Seog Oh', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}