Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT03014557
Status:
UNKNOWN
Last Update Posted:
2017-01-09
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China REgistry of WATCHMAN
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 413}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause death, ischemic stroke, systemic embolism, or device or procedure related events', 'timeFrame': 'between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later', 'description': 'events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.'}, {'measure': 'composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Implantation success rate.', 'timeFrame': 'procedure', 'description': 'Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary.'}, {'measure': 'Ischemic stroke or systemic embolism', 'timeFrame': 'excluding the first 7 days post enrollment.'}, {'measure': 'All Major Complications.', 'timeFrame': 'up to 5 years', 'description': 'Major complication is defined as death, stroke, MI or any other serious adverse events related to the device or procedure.'}, {'measure': 'All-cause death.', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'left atrial appendage closure', 'WATCHMAN'], 'conditions': ['Atrial Fibrillation', 'Left Atrial Appendage Closure']}, 'descriptionModule': {'briefSummary': 'This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.', 'detailedDescription': 'In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'non-valvular atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNon-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:\n\n1. not suitable for long-term anti-coagulation therapy;\n2. stroke or embolism events in spite of warfarin treatment with intended INR\n3. HAS-BLED≥3\n\nExclusion Criteria:\n\nPatient with any one of the following items will be excluded from the study:\n\n1\\. clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life \\< 5 years\n\n2 Echocardiography exclusion criteria (any of the items) a LVEF\\<30% b thrombus or spontaneous echo imaging detected within two days prior to procedure c patent foramen ovale d cardiac tumor e left atrial appendage orifice diameter \\>32mm or \\< 17mm f the depth of left atrial appendage is less than the width g prominent mitral stenosis (area \\<1.5cm2)\n\n3 subject is not able to or will not complete the follow ups as planned'}, 'identificationModule': {'nctId': 'NCT03014557', 'acronym': 'CREW', 'briefTitle': 'China REgistry of WATCHMAN', 'organization': {'class': 'OTHER', 'fullName': 'Fu Wai Hospital, Beijing, China'}, 'officialTitle': 'China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'T2016-ZX021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'WATCHMAN', 'description': 'subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device', 'interventionNames': ['Device: left atrial appendage closure device implantation']}], 'interventions': [{'name': 'left atrial appendage closure device implantation', 'type': 'DEVICE', 'description': 'to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach', 'armGroupLabels': ['WATCHMAN']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengqin Zhai, MD PhD', 'role': 'CONTACT', 'email': '384358085@qq.com'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhengqin Zhai, MD PhD', 'role': 'CONTACT', 'email': '384358085@qq.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Wai Hospital, Beijing, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Arrhythmia', 'investigatorFullName': 'Shu Zhang', 'investigatorAffiliation': 'Fu Wai Hospital, Beijing, China'}}}}