Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 5:44 PM
Study NCT ID:
NCT02358551
Status:
UNKNOWN
Last Update Posted:
2015-02-09
First Post:
2015-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2015-01-25', 'studyFirstSubmitQcDate': '2015-02-03', 'lastUpdatePostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of vein puncture', 'timeFrame': '1 Day'}], 'secondaryOutcomes': [{'measure': 'Mechanical complication of electrode lead (combined endpoints of hemothorax, pneumothorax, air embolism, inadvertent arterial puncture, hematoma, fracture of electrode lead, nerve injury and subclavian crush syndrome)', 'timeFrame': '6 months'}, {'measure': 'Duration of pacemaker implantation', 'timeFrame': '1 Day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pacemaker', 'Axillary Vein', 'Subclavian vein', 'Clinical Study', 'Cardiovascular implantable electronic devices'], 'conditions': ['Mechanical Complication of Cardiac Pacemaker']}, 'referencesModule': {'references': [{'pmid': '27823994', 'type': 'DERIVED', 'citation': 'Liu P, Zhou YF, Yang P, Gao YS, Zhao GR, Ren SY, Li XL. Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study. Chin Med J (Engl). 2016 Nov 20;129(22):2647-2651. doi: 10.4103/0366-6999.193462.'}]}, 'descriptionModule': {'briefSummary': 'The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush, but clinical adoption is not widely acknowledged, especially in China, although this approach has been proposed for 20 years. The major concern is the learning curve for axillary vein puncture and its success rate. The investigators try to prove that the success rate of axillary vein puncture is non-inferior to subclavian vein puncture, hence to promote the clinical application of axillary vein puncture to reduce pacemaker implantation complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with indication of pacemaker or ICD implantation\n* Personally signed and dated informed consent document\n\nExclusion Criteria:\n\n* Accompanied with malignant disease or other disease, which cause life expectancy \\< 1 year.\n* Anatomical variation of axillary vein or subclavian vein, unable to puncture.\n* Poor compliance for follow-up.\n* Patients with any condition which, in the investigator's judgment, not suitable for enrollment."}, 'identificationModule': {'nctId': 'NCT02358551', 'briefTitle': 'Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation', 'orgStudyIdInfo': {'id': 'CJFH-2014-086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Axillary vein', 'description': 'Lead Placement Through the Axillary Vein Technique', 'interventionNames': ['Device: Placement of electrode lead through axillary vein puncture']}, {'type': 'OTHER', 'label': 'Subclaivan vein', 'description': 'Lead Placement Through the Subclavian Vein Technique', 'interventionNames': ['Device: Placement of electrode lead through subclavian vein puncture']}], 'interventions': [{'name': 'Placement of electrode lead through axillary vein puncture', 'type': 'DEVICE', 'armGroupLabels': ['Axillary vein']}, {'name': 'Placement of electrode lead through subclavian vein puncture', 'type': 'DEVICE', 'armGroupLabels': ['Subclaivan vein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Wang, MD', 'role': 'CONTACT', 'email': 'zryyyb@126.com', 'phone': '86-10-84205566'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xianlun Li, MD', 'role': 'CONTACT', 'email': 'leexianlun@163.com', 'phone': '86-10-84206151'}, {'name': 'Peng Liu, MD, PhD', 'role': 'CONTACT', 'email': 'liupengdoc@gmail.com', 'phone': '86-10-84205136'}], 'overallOfficials': [{'name': 'Xianlun Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director, Department of Cardiology', 'investigatorFullName': 'Xianlun Li', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}