Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2026-03-01 @ 3:55 PM
Study NCT ID:
NCT03040661
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Sponsor:
Organization:
Raw JSON
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'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 2, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Manual Hemostasis Group', 'description': 'Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.\n\nAblation for atrial fibrillation', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 2, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hematoma or minor bleeding at site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 35, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Required to Achieve Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Figure of 8 Suture', 'description': 'Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.\n\nAblation for atrial fibrillation.'}, {'id': 'OG001', 'title': 'Manual Hemostasis Group', 'description': 'Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.\n\nAblation for atrial fibrillation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '15', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time (minutes) from sheath removal till hemostasis achieved', 'description': 'Time Required to Achieve Hemostasis (minutes)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Figure of 8 Suture', 'description': 'Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.\n\nAblation for atrial fibrillation.'}, {'id': 'OG001', 'title': 'Manual Hemostasis Group', 'description': 'Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.\n\nAblation for atrial fibrillation'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '5', 'groupId': 'OG000'}, {'value': '28', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time (minutes) from completion of procedure till patient leaves room', 'description': 'Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Figure of 8 Suture', 'description': 'Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.\n\nAblation for atrial fibrillation.'}, {'id': 'OG001', 'title': 'Manual Hemostasis Group', 'description': 'Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.\n\nAblation for atrial fibrillation'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed after sheath removal till patient discharge', 'description': 'Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Figure of 8 Suture', 'description': 'Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.\n\nAblation for atrial fibrillation.: Ablation for atrial fibrillation.'}, {'id': 'FG001', 'title': 'Manual Hemostasis Group', 'description': 'Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.\n\nAblation for atrial fibrillation.: Ablation for atrial fibrillation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Figure of 8 Suture', 'description': 'Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.\n\nAblation for atrial fibrillation.: Ablation for atrial fibrillation.'}, {'id': 'BG001', 'title': 'Manual Hemostasis Group', 'description': 'Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.\n\nAblation for atrial fibrillation.: Ablation for atrial fibrillation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-02', 'size': 228453, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-31T11:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2017-01-24', 'resultsFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-23', 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Required to Achieve Hemostasis', 'timeFrame': 'Time (minutes) from sheath removal till hemostasis achieved', 'description': 'Time Required to Achieve Hemostasis (minutes)'}, {'measure': 'Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.', 'timeFrame': 'Time (minutes) from completion of procedure till patient leaves room', 'description': 'Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)'}], 'secondaryOutcomes': [{'measure': 'Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group', 'timeFrame': 'Assessed after sheath removal till patient discharge', 'description': 'Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the procedure, heparin is administered to maintain a target ACT \\> 300 seconds. At the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked 20" later, and if \\< 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure\n\nExclusion Criteria:\n\n1. Pregnant patients.\n2. Age \\<18 years.\n3. Patients who cannot provide consent in English.\n4. Prisoners.'}, 'identificationModule': {'nctId': 'NCT03040661', 'acronym': 'Figure 8', 'briefTitle': 'Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture', 'orgStudyIdInfo': {'id': '16-2381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Figure of 8 Suture', 'description': 'Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.', 'interventionNames': ['Procedure: Ablation for atrial fibrillation.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Hemostasis Group', 'description': 'Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.', 'interventionNames': ['Procedure: Ablation for atrial fibrillation.']}], 'interventions': [{'name': 'Ablation for atrial fibrillation.', 'type': 'PROCEDURE', 'description': 'Ablation for atrial fibrillation.', 'armGroupLabels': ['Figure of 8 Suture', 'Manual Hemostasis Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}