Nctid:
NCT06232278
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000083262", "term"=>"Embolic Stroke"}, {"id"=>"D001281", "term"=>"Atrial Fibrillation"}, {"id"=>"D013927", "term"=>"Thrombosis"}], "ancestors"=>[{"id"=>"D001145", "term"=>"Arrhythmias, Cardiac"}, {"id"=>"D006331", "term"=>"Heart Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D016769", "term"=>"Embolism and Thrombosis"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D000083242", "term"=>"Ischemic Stroke"}, {"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"}], "browseLeaves"=>[{"id"=>"M4586", "name"=>"Atrial Fibrillation", "asFound"=>"Atrial Fibrillation", "relevance"=>"HIGH"}, {"id"=>"M9556", "name"=>"Hemorrhage", "relevance"=>"LOW"}, {"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}, {"id"=>"M16686", "name"=>"Thrombosis", "asFound"=>"Thrombosis", "relevance"=>"HIGH"}, {"id"=>"M2402", "name"=>"Embolic Stroke", "asFound"=>"Cardioembolic Stroke", "relevance"=>"HIGH"}, {"id"=>"M4453", "name"=>"Arrhythmias, Cardiac", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"M7784", "name"=>"Embolism", "relevance"=>"LOW"}, {"id"=>"M19128", "name"=>"Embolism and Thrombosis", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "relevance"=>"LOW"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-05-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-08-08", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-09", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Effectiveness of left atrial appendage occlusion with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories", "timeFrame"=>"From 15 February 2024 to 15 April 2024", "description"=>"Effectiveness is assessed by a composit endpoint that combines transient ischemic attack (TIA)/stroke, systemic embolism, cardiovascular mortality or All-cause mortality"}], "secondaryOutcomes"=>[{"measure"=>"Safety of left atrial appendage occlusion (LAAO) with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratoriesleft atrial.", "timeFrame"=>"At 8 weeks", "description"=>"The safety is defined as occurrence of events related to the device (device embolization, the presence of visible thrombus on the surface of the device, significant peri-device leak) and events related to the procedure (serious pericardial effusion requiring drainage, intracranial or gastrointestinal bleeding or other major bleeding requiring transfusion)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Left atrial appendage occlusion · WATCHMAN · AMPLATZER Amulet · Atrial fbrillation · Stroke · Echocardiography · Cardiac computed tomography angiography"], "conditions"=>["Atrial Fibrillation", "Cardioembolic Stroke", "Left Atrial Appendage Thrombosis", "Anticoagulant-induced Bleeding"]}, "descriptionModule"=>{"briefSummary"=>"Atrial Fibrillation represents an important risk of cardioembolic stroke. In more than 90% of cases, thrombus originate in the left atrial appendage. Therefore guidelines recommend the anticoagulation of patients with atrial fibrillation and a significant cardioembolic risk, predicted by the CHA2DS2VASc score.\n\nHowever, serious bleeding complications may definitively contraindicate the use of anticoagulants.\n\nFor those patients, percutaneous Left Atrial Appendage Occlusion (LAAO) has became a recommended alternative to prevent the thrombus formation and reduce the risk of cardioembolic events.\n\nIn the CHU of Brest, more than 120 patients have been treated with LAAO for the last 8 years with two different occluder devices : WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories.\n\nThis retrospective longitudinal observational study named CLAPOT (CHU of Brest' Left Atrial Appendage Percutaneous Occlusion Treatment) aims to evaluate the long term results of this procedure for effectiveness and safety and to compare the results between the two devices (Watchman and Amplatzer)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"All patients with non-valvular atrial fibrillation and a definitive contraindication to anticoagulants who underwent left atrial appendage occlusion in the CHU of Brest between December 2014 and August 2023", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Major\n* Non opposition\n* All patients with non-valvular atrial fibrillation and a definitive contraindication to anticoagulants who underwent left atrial appendage occlusion in the CHU of Brest between December 2014 and August 2023\n\nExclusion Criteria:\n\n* Minor\n* Patients under tutorship or curatorship\n* Formulated opposition"}, "identificationModule"=>{"nctId"=>"NCT06232278", "acronym"=>"CLAPOT", "briefTitle"=>"Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital (CLAPOT)", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Brest"}, "officialTitle"=>"Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital.", "orgStudyIdInfo"=>{"id"=>"29BRC23.0255 - CLAPOT"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"29609", "city"=>"Brest", "country"=>"France", "facility"=>"Chu Brest", "geoPoint"=>{"lat"=>48.3903, "lon"=>-4.48628}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"Data will be available beginning three years and ending fifteen years following the final study report completion", "ipdSharing"=>"YES", "description"=>"All collected data that underlie results in a publication", "accessCriteria"=>"Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Brest", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
