Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT06405750
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': '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': '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': 'D000097546', 'term': 'Left Atrial Appendage Closure'}], 'ancestors': [{'id': 'D006328', 'term': 'Cardiac Catheterization'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Mechanistic study based on analysis of biological material collected along with electrocardiogram features on individuals undergoing open-heart surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-05-05', 'studyFirstSubmitQcDate': '2024-05-05', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stroke', 'timeFrame': 'six years', 'description': 'number of patients with clinical stroke'}], 'secondaryOutcomes': [{'measure': 'perioperative atrial fibrillation', 'timeFrame': '30 days', 'description': 'number of patients with incident atrial fibrillation the days after surgery, prior to discharge'}, {'measure': 'silent brain infarctions', 'timeFrame': 'six years', 'description': 'number of patients in whom asymptomatic ischemic infarctions are identified in brain scans (CTC or MRI)'}, {'measure': 'occurrence of atrial fibrillation during follow-up', 'timeFrame': 'ten years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart surgery', 'atrial myocardiopathy', 'arrhythmogenic substrate', 'stroke', 'cerebral transitory ischemic attack', 'thrombogenesis', 'cardiac embolism'], 'conditions': ['Atrial Fibrillation', 'Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.\n\nIn connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. This procedure is common in patients with atrial fibrillation to protect the brain from stroke. In the project, all patients will have this auricle closed if they agree to participate in the project.\n\nAfter closure, the auricle is usually discarded. We will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.', 'detailedDescription': 'Patients scheduled for elective heart surgery are invited to participate. After informed consent is signed, an ECG and blood samples are gathered the day before surgery or the same day of the surgery is planned.\n\nDuring surgery, the patients undergo closure of the left atrial appendage (LAA). The choice of the device is at the discretion of the surgeon. If possible, the entire LAA is removed and processed for further analysis. The right atrial appendage is likewise removed and follows the same procedure as the LAA.\n\nThe analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers.\n\nThe right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent AND\n* planned any open-heart surgery:\n\n * CABG\n * valve repair or replacement\n * aorta surgery\n * any combination of the above\n\nExclusion Criteria:\n\n* current endocarditis\n* follow-up not possible'}, 'identificationModule': {'nctId': 'NCT06405750', 'acronym': 'LAATAS', 'briefTitle': 'Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Bispebjerg and Frederiksberg'}, 'officialTitle': 'Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate', 'orgStudyIdInfo': {'id': 'H-23015282'}, 'secondaryIdInfos': [{'id': 'P-2023-227', 'type': 'OTHER', 'domain': 'Capital Region Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LAA closure', 'description': 'All patients included in the study undergo closure of the Left Atrial Appendage', 'interventionNames': ['Procedure: left atrial appendage closure']}], 'interventions': [{'name': 'left atrial appendage closure', 'type': 'PROCEDURE', 'description': 'systematic closure of the left atrial appendage in addition to the planned heart surgery', 'armGroupLabels': ['LAA closure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christian L Carranza', 'role': 'CONTACT'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Helena DOMINGUEZ, MD, PhD', 'role': 'CONTACT', 'email': 'mdom0002@regionh.dk', 'phone': '4522989343'}, {'name': 'Ida Gustafsson, MD, PhD', 'role': 'CONTACT', 'email': 'ida.gustafsson@regionh.dk', 'phone': '4538635000'}], 'overallOfficials': [{'name': 'Helena Dominguez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Bispebjerg and Frederiksberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Bispebjerg and Frederiksberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor', 'investigatorFullName': 'Helena DOMINGUEZ', 'investigatorAffiliation': 'University Hospital Bispebjerg and Frederiksberg'}}}}