Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-28 @ 6:50 AM
Study NCT ID:
NCT02252861
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Database of Left Atrial Appendage Closure
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': 'ACTUAL', 'count': 840}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2014-09-22', 'studyFirstSubmitQcDate': '2014-09-26', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)', 'timeFrame': '1 year'}, {'measure': 'Death rate from cardiovascular disease after left atrial appendage closure', 'timeFrame': '1 year'}, {'measure': 'Unexplained Death rate after left atrial appendage closure', 'timeFrame': '1 year'}, {'measure': 'Adverse events related to the procedure', 'timeFrame': '1 year'}, {'measure': 'Cost of the procedure of left atrial appendage closure', 'timeFrame': 'Costs will be assessed for the duration of hospital stay, an expected average of 3 days'}, {'measure': 'Cost of patient follow-up after left atrial appendage closure', 'timeFrame': '1 year'}, {'measure': 'Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation and Other Dysrhythmias | Patient']}, 'referencesModule': {'references': [{'pmid': '34051135', 'type': 'DERIVED', 'citation': 'Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Spaulding C, Armero S, Champagnac D, Bhugaloo H, Ternacle J, Lellouche N, Audureau E, Le Corvoisier P; French national Left Atrial Appendage Closure registry (FLAAC) investigators. Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry. Catheter Cardiovasc Interv. 2021 Oct;98(4):788-799. doi: 10.1002/ccd.29795. Epub 2021 May 29.'}, {'pmid': '29540492', 'type': 'DERIVED', 'citation': 'Teiger E, Thambo JB, Defaye P, Hermida JS, Abbey S, Klug D, Juliard JM, Pasquie JL, Rioufol G, Lepillier A, Elbaz M, Horvilleur J, Brenot P, Pierre B, Le Corvoisier P; French National Left Atrial Appendage Closure Registry (FLAAC) Investigators. Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events. Circ Cardiovasc Interv. 2018 Mar;11(3):e005841. doi: 10.1161/CIRCINTERVENTIONS.117.005841.'}]}, 'descriptionModule': {'briefSummary': 'Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy.\n\nThis national database record per-procedure and follow-up data of patients treated by left atrial appendage closure.\n\nThis database is strictly observational.\n\nPercutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred for percutaneous Left Atrial Appendage Closure to one of the French centers involved in this database', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care\n* Signature of an inform consent form for inclusion of data recorded during care in the database\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT02252861', 'acronym': 'FLAAC', 'briefTitle': 'French Database of Left Atrial Appendage Closure', 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': 'French Database of Left Atrial Appendage Closure', 'orgStudyIdInfo': {'id': 'FLAAC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Left Atrial Appendage Closure', 'description': 'Patients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care', 'interventionNames': ['Other: Percutaneous Left Atrial Appendage Closure in routine care']}], 'interventions': [{'name': 'Percutaneous Left Atrial Appendage Closure in routine care', 'type': 'OTHER', 'description': 'The inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.', 'armGroupLabels': ['Left Atrial Appendage Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Emmanuel Teiger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'emmanuel.teiger@hmn.aphp.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'French association for research in cardiology (ARCARD)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Philippe Le Corvoisier', 'investigatorAffiliation': 'Henri Mondor University Hospital'}}}}