Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-20 @ 6:24 PM
Study NCT ID:
NCT03693092
Status:
UNKNOWN
Last Update Posted:
2018-10-02
First Post:
2018-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LAmbre™ Left Atrial Appendage Closure System Follow-Up Study
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-30', 'studyFirstSubmitDate': '2018-09-30', 'studyFirstSubmitQcDate': '2018-09-30', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of compound event', 'timeFrame': '5 years after the surgery', 'description': 'The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).'}], 'secondaryOutcomes': [{'measure': 'The incidence of MACCE events', 'timeFrame': '2,3,4,5 years postoperative follow-up.', 'description': 'The MACCE events including death (All cause death, All-cause death includes cardiac death, non-cardiac death and unexplained death), stroke, cardiac tamponade, and renal failure.'}, {'measure': 'Ischemic stroke rate', 'timeFrame': '2,3,4,5 years postoperative follow-up', 'description': 'Ischemic stroke is a neurological deficit caused by transient ischemic attack, cerebral thrombosis or cerebral embolism.'}, {'measure': 'The rate of stroke', 'timeFrame': '2,3,4,5 years postoperative follow-up', 'description': 'Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA).'}, {'measure': 'The event of bleeding', 'timeFrame': '2,3,4,5 years postoperative follow-up', 'description': 'Intracranial or alimentary canal, or any bleeding that requires transfusion of 2 units of red blood cell suspension.'}, {'measure': 'Cardiac events', 'timeFrame': '2,3,4,5 years postoperative follow-up', 'description': 'Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. The follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of LAmbre™ LAA Closure System.', 'detailedDescription': "All subjects who completed 1-year follow-up of the LAmbreTM LAA system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call.\n\nDuring the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.\n\nThe inclusion criteria of LAmbreTM Safety and Efficacy Study:\n\n1. Age\\>=18, CHADS2 score\\>=1\n2. Patients cannot be treated long-term with Warfarin\n3. Eligible for clopidogrel and aspirin\n4. Provide written informed consent and agree to comply with the required follow-ups\n\nExclusion Criteria:\n\n\\- Exclusion criteria: Patients who did not participate in the LAmbreTM Safety and Efficacy Study or did not complete 1-year follow-up LAmbreTM Safety and Efficacy Study.\n\nThe exclusion criteria of LAmbreTM Safety and Efficacy Study:\n\n1. Need to take Warfarin\n2. Presence of rheumatic, degenerative or congenital valvular heart diseases\n3. Early stage or paroxysmal atrial fibrillation\n4. Symptomatic patients with carotid artery disease (such as carotid stenosis\\>=50%)\n5. Heart failure NYHA grade IV\n6. Recent 30 days stroke or TIA\n7. Presence of active sepsis or endocarditis\n8. Cardiac tumours or other malignancy with estimated life expectancy \\<2 years\n9. Abnormal blood test; renal dysfunction\n10. LAA removed or heart implant patients\n11. Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system\n12. Patients have a history of mechanical prosthesis operation\n13. Patients who are pregnant, or desire to be pregnant during the during the study\n14. Participation in other trials\n15. A known allergy to nitinol\n16. Patients will not be able to complete the trial'}, 'identificationModule': {'nctId': 'NCT03693092', 'briefTitle': 'LAmbre™ Left Atrial Appendage Closure System Follow-Up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lifetech Scientific (Shenzhen) Co., Ltd.'}, 'officialTitle': 'LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study', 'orgStudyIdInfo': {'id': 'LAA 2-5ys FU'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chaoyang Hospital, Capital Medical university', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yan Yao', 'role': 'CONTACT'}], 'facility': 'Fuwai Hospital Chinese Academy of Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'contacts': [{'name': 'Bo Yu', 'role': 'CONTACT'}], 'facility': 'The 2nd Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Congxin Huang', 'role': 'CONTACT'}], 'facility': "People's Hospital of Wuhan University", 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Xi Su', 'role': 'CONTACT'}], 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Minglong Chen', 'role': 'CONTACT'}], 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'contacts': [{'name': 'Zulu Wang', 'role': 'CONTACT'}], 'facility': 'The General Hospital of Shenyang Military Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Dalian', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Yanzong Yang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Dalian Medical University'}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Yawei Xu', 'role': 'CONTACT'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Yigang Li', 'role': 'CONTACT'}], 'facility': 'Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Chengdu', 'country': 'China', 'contacts': [{'name': 'Jian Jiang', 'role': 'CONTACT'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Ying Xia', 'role': 'CONTACT', 'email': 'xiaying@lifetechmed.com', 'phone': '+86 13760184511'}], 'overallOfficials': [{'name': 'Congxin Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Wuhan University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lifetech Scientific (Shenzhen) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}