Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 2:56 AM
Study NCT ID:
NCT05761704
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Observation of Two Short-term Regimens After LAA Occlusion by LAMax LAAC® Device for Subjects With Non-valvular Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-05-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of device-related thrombosis', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of device-related thrombosis (DRT) at the visit of 4 weeks post-LAAC documented by CTA and the visit of 24 weeks post-LAAC documented by transesophageal echocardiogram (TEE).'}, {'measure': 'Incidence of stroke and transient ischemic attack', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of stroke (classified as ischemic, hemorrhagic, or unspecified) and transient ischemic attack (TIA) before discharge or at 7 days, 4 weeks, and 24 weeks post-LAAC.'}], 'secondaryOutcomes': [{'measure': 'Incidence of bleeding events', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of bleeding events before discharge or at 7 days, 4 weeks, and 24 weeks post-LAAC.'}, {'measure': 'Incidence of systemic embolic events', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of systemic embolic events before discharge or at 7 days, 4 weeks, and 24 weeks post-LAAC.'}, {'measure': 'Incidence of procedure-related complications', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of procedure-related complications (including device embolization, significant pericardial effusion) before discharge or at 7 days, 4 weeks, and 24 weeks post-LAAC.'}, {'measure': 'Incidence of composite clinical endpoint events', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of composite clinical endpoint events (including death, myocardial infarction, stroke, TIA) before discharge or at 7 days, 4 weeks, and 24 weeks post-LAAC.'}, {'measure': 'Incidence of all-cause mortality', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of all-cause mortality (including cardiac death, non-cardiac death, and unexplained death) before discharge or at 7 days, 4 weeks, and 24 weeks post-LAAC.'}, {'measure': 'Incidence of myocardial infarction', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of myocardial infarction before discharge or at 7 days, 4 weeks and 24 weeks post-LAAC.'}, {'measure': 'Incidence of major bleeding', 'timeFrame': '24 weeks post-LAAC', 'description': 'Incidence of major bleeding (BARC type 3 and 5) before discharge or at 7 days, 4 weeks and 24 weeks post-LAAC.'}, {'measure': 'Adverse events', 'timeFrame': '24 weeks post-LAAC', 'description': 'Adverse events on the day of surgery, before discharge, or at 7 days, 4 weeks, and 24 weeks post-LAAC.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Left Atrial Appendage Closure', 'Ischemic Stroke', 'Device-related Thrombosis'], 'conditions': ['Non-valvular Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-center, randomized, exploratory clinical observation to explore the overall benefit of short-term dual antiplatelet or novel oral anticoagulant regimens after left atrial appendage (LAA) occlusion by LAMax LAAC® occluder for subjects with non-valvular atrial fibrillation (AF), which will provide a basis for subsequent research on real-world safety and efficacy of LAA closure (LAAC).', 'detailedDescription': 'Anticoagulation is necessary after transcatheter left atrial appendage closure (LAAC) and is important to prevent thrombosis and device-related thrombosis (DRT). Bleeding events and stroke should be reduced while reducing thrombosis. Based on the characteristics of the LAMax LAAC® device, experts recommend studying short-term medication regimens for patients with non-valvular atrial fibrillation after LAAC. This trial is a prospective, single-center, randomized, open-label and parallel design. It is estimated that 54 patients will take part in the study. Subjects with non-valvular atrial fibrillation undergo transcatheter LAAC using the LAMax LAAC® device, and then are randomly enrolled in observation group 1/observation group 2 of the medication regimen in a 1:1 ratio after LAAC.\n\nObservation group 1 (dual antiplatelet group, 27 subjects): 4 weeks post-LAAC (aspirin 100 mg + clopidogrel 75 mg); 4-24 weeks post-LAAC (aspirin/clopidogrel); recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).\n\nObservation group 2 (novel oral anticoagulant group, 27 subjects): 4 weeks post-LAAC (conventional dose NOAC); 4-24 weeks post-LAAC (aspirin/clopidogrel); recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients ≥ 18 years old with non-valvular atrial fibrillation (AF);\n* 2\\. Subjects with LAAC indications: according to the 2023 SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Attachment Closure, transcatheter LAAC is suitable for non-valvular AF patients with high risk of thromboembolism but unsuitable for long-term use of oral anticoagulants (OACs), including the following situations:\n\n 1. Have a much higher risk of having stroke (CHA2DS2-VASc score: male ≥ 2 points, female ≥ 3 points),\n 2. Have OAC intolerance or a much higher risk of bleeding (such as HAS-BLED score ≥ 3 points),\n 3. Have sufficient life expectancy (minimum\\>1 year) and expected to improve quality of life after LAAC;\n* 3\\. Successful left atrial appendage occlusion with LAMax LAAC® device;\n* 4\\. Patients and their families fully understand the purpose of the study, voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Combined with other diseases except AF requiring long-term warfarin or other anticoagulant therapy;\n* 2\\. Absolute contraindications for anticoagulation therapy or unacceptable bleeding risk with dual antiplatelet therapy;\n* 3\\. Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization);\n* 4\\. Occluder dislocation, pericardial effusion (including new pericardial effusion and significantly increased pre-existing pericardial effusion) and other bleeding complications within 24 hours after LAAC;\n* 5\\. Patients scheduled for catheter ablation after left atrial appendage electrical isolation and during the study;\n* 6\\. Patients resistant to clopidogrel;\n* 7\\. Patients requiring elective cardiac surgery;\n* 8\\. Heart failure NYHA grade IV and not been corrected yet;\n* 9\\. Patients with AF caused by rheumatic valvular heart disease, degenerative valvular heart disease, congenital valvular heart disease, severe mitral stenosis, aortic stenosis and other valvular diseases;\n* 10\\. Initial atrial fibrillation, paroxysmal atrial fibrillation with a clear cause such as coronary artery bypass grafting (CABG) \\< 12 months, hyperthyroidism, etc.\n* 11\\. Patients with acute myocardial infarction or unstable angina pectoris, or recent myocardial infarction \\< 12 months;\n* 12\\. Patients with active bleeding, bleeding constitution or bleeding disorders, coagulation history and unhealed gastrointestinal ulcer;\n* 13\\. Infective endocarditis, vegetation or other infections causing bacteremia, sepsis;\n* 14\\. Female patients who are pregnant, lactating, or planning to become pregnant during this study;\n* 15\\. Patients who have participated in other drug or device clinical trials and have not reached the endpoint;\n* 16\\. Patients with renal insufficiency (endogenous creatinine clearance \\< 30ml/min) (using the standard Crockcroft-Gault formula) and/or advanced renal disease requiring dialysis;\n* 17\\. Severe hepatic dysfunction (AST/ALT greater than 5 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal);\n* 18\\. Patients considered unsuitable for this study by the investigator.\n* 19\\. Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;\n* 20\\. Post prosthetic heart valve replacement;\n* 21\\. Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;\n* 22\\. Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;\n* 23\\. LVEF（left ventricular ejection fraction, by Simpson method）\\<35%；\n* 24\\. Clear thrombus is found in the heart before LAAC;\n* 25\\. TEE examination: the maximal orifice diameter of LAA is less than 12 mm, or more than 36 mm;\n* 26\\. Residual flow after LAAC \\>5mm；\n* 27\\. Patent foramen ovale with high risk;\n* 28\\. Mitral stenosis with a valve area \\<1.5cm2;\n* 29\\. Left atrial diameter (antero-posterior diameter) \\> 65mm, or pericardial effusion more than a small amount, the depth of local effusion \\> 10 mm;\n* 30\\. Contraindications to X-ray, or not suitable for TEE examination.'}, 'identificationModule': {'nctId': 'NCT05761704', 'briefTitle': 'Exploratory Observation of Two Short-term Regimens After LAA Occlusion by LAMax LAAC® Device for Subjects With Non-valvular Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Prospective Exploratory Clinical Observation of Two Short-term Regimens (Dual Antiplatelet or Novel Oral Anticoagulant) for Subjects With Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion by LAMax LAAC® Device', 'orgStudyIdInfo': {'id': 'SAHZJU CT021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual antiplatelet', 'description': 'Aspirin 100 mg + clopidogrel 75 mg for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).', 'interventionNames': ['Drug: Dual antiplatelet']}, {'type': 'EXPERIMENTAL', 'label': 'Novel oral anticoagulant', 'description': 'Conventional dose NOAC for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).', 'interventionNames': ['Drug: Novel oral anticoagulant']}], 'interventions': [{'name': 'Dual antiplatelet', 'type': 'DRUG', 'description': 'Aspirin 100 mg + clopidogrel 75 mg for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).', 'armGroupLabels': ['Dual antiplatelet']}, {'name': 'Novel oral anticoagulant', 'type': 'DRUG', 'description': 'Conventional dose NOAC for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).', 'armGroupLabels': ['Novel oral anticoagulant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youqi Fan, MD', 'role': 'CONTACT', 'email': 'fanyouqi1228@126.com', 'phone': '+86-13867482684'}, {'name': 'Jian-an Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '2nd Affiliated Hospital, School of Medicine at Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Youqi Fan', 'role': 'CONTACT', 'email': 'fanyouqi1228@126.com', 'phone': '+86-13867482684'}, {'name': "Jian'an Wang", 'role': 'CONTACT', 'email': 'wangjianan111@zju.edu.cn', 'phone': '+86-13805786328'}], 'overallOfficials': [{'name': 'Youqi Fan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': "Jian'an Wang,MD,PhD", 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}