Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-30 @ 8:12 AM
Study NCT ID:
NCT05478304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2022-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6573}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2032-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Endpoint', 'timeFrame': 'Common termination point (median follow-up for 5 years)', 'description': 'Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.'}, {'measure': 'Primary Safety Endpoint', 'timeFrame': '30 days post index procedure', 'description': 'Occurrence of at least one of the following events assessed through 30 days post index procedure:\n\n* Pericardial effusion requiring percutaneous or surgical treatment\n* Major bleeding attributable to index surgical procedure\n* Deep sternal wound infection\n* Myocardial infarction'}], 'secondaryOutcomes': [{'measure': 'Powered Secondary Effectiveness endpoint', 'timeFrame': 'Common termination point (median follow-up for 5 years)', 'description': 'Time to the first occurrence of ischemic stroke or systemic arterial embolism'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ischemic Stroke', 'Systemic Embolism']}, 'referencesModule': {'references': [{'pmid': '39395566', 'type': 'DERIVED', 'citation': 'Whitlock RP, McCarthy PM, Gerdisch MW, Ramlawi B, Alexander JH, Sultan I, Rose DZ, Healey JS, Sharma YA, Belley-Cote EP, Connolly SJ. The left atrial appendage exclusion for prophylactic stroke reduction (LEAAPS) trial: Rationale and design. Am Heart J. 2025 Jun;284:94-102. doi: 10.1016/j.ahj.2024.10.006. Epub 2024 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects ≥ 18 years of age\n* Documentation of any of the following clinical criteria:\n\n * CHA2DS2-VASc ≥ 4 with age ≥ 65\n * CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP\n * CHA2DS2-VASc = 3 with age ≥ 75\n * CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP\n * CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP\n\nExclusion Criteria:\n\n* Clinically significant atrial fibrillation or atrial flutter:\n\n * Anytime in the past and\n * Documented by an electrocardiographic recording and\n * Episode lasting 6 minutes or longer1\\*\n* Prior procedure involving opening the pericardium or entering the pericardial space\n* Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)\n* Planned cardiac surgical procedure using non-sternotomy approaches\n\n o Partial sternotomies will be allowed.\n* Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices\n* Active endocarditis\n* Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms\n* Known allergy to Nitinol or nickel sensitivity\n* Known medical condition with expected survival of less than 1 year\n* Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.\n* Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.\n* Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.\n* Pregnancy\n* Known severe symptomatic carotid disease"}, 'identificationModule': {'nctId': 'NCT05478304', 'acronym': 'LeAAPS', 'briefTitle': 'Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'AtriCure, Inc.'}, 'officialTitle': 'Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial', 'orgStudyIdInfo': {'id': 'CP-2021-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery', 'interventionNames': ['Device: AtriClip LAA Exclusion System']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No LAAE concomitant to and at the time of planned cardiac surgery'}], 'interventions': [{'name': 'AtriClip LAA Exclusion System', 'type': 'DEVICE', 'description': 'LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research / Huntsville Hospital', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth Shea Scottsdale Healthcare', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': "St. Bernard's Heart & Vascular", 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'CHI St. Vincent', 'geoPoint': {'lat': 34.74648, 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