Nctid:
NCT06236776
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000054092", "term"=>"Foramen Ovale, Patent"}, {"id"=>"D000006344", "term"=>"Heart Septal Defects, Atrial"}], "ancestors"=>[{"id"=>"D000006343", "term"=>"Heart Septal Defects"}, {"id"=>"D000006330", "term"=>"Heart Defects, Congenital"}, {"id"=>"D000018376", "term"=>"Cardiovascular Abnormalities"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000000013", "term"=>"Congenital Abnormalities"}], "browseLeaves"=>[{"id"=>"M4453", "name"=>"Arrhythmias, Cardiac", "relevance"=>"LOW"}, {"id"=>"M27570", "name"=>"Foramen Ovale, Patent", "asFound"=>"Patent Foramen Ovale", "relevance"=>"HIGH"}, {"id"=>"M9431", "name"=>"Heart Septal Defects", "relevance"=>"LOW"}, {"id"=>"M9432", "name"=>"Heart Septal Defects, Atrial", "asFound"=>"Atrial Septal Defect", "relevance"=>"HIGH"}, {"id"=>"M9418", "name"=>"Heart Defects, Congenital", "relevance"=>"LOW"}, {"id"=>"M12", "name"=>"Congenital Abnormalities", "relevance"=>"LOW"}, {"id"=>"M20503", "name"=>"Cardiovascular Abnormalities", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>150}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2028-06", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2023-11-10", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Occurrence of atrial fibrillation", "timeFrame"=>"Immediate post-operative", "description"=>"Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring"}, {"measure"=>"Occurrence of atrial fibrillation", "timeFrame"=>"18 month", "description"=>"Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring"}, {"measure"=>"Occurrence of atrial fibrillation", "timeFrame"=>"30 month", "description"=>"Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring"}], "secondaryOutcomes"=>[{"measure"=>"All cause-death", "timeFrame"=>"Immediate post-operative, 18 month , 30 month"}, {"measure"=>"hospitalization for heart failure", "timeFrame"=>"Immediate post-operative, 18 month , 30 month", "description"=>"hospitalization for heart failure: data from electronic medical record in Yonsei university health system"}, {"measure"=>"new atrial fibrillation", "timeFrame"=>"Immediate post-operative, 18 month , 30 month"}, {"measure"=>"new atrial tachycardia", "timeFrame"=>"Immediate post-operative, 18 month , 30 month"}, {"measure"=>"high burden of APC/PVC (>15%)", "timeFrame"=>"Immediate post-operative, 18 month , 30 month", "description"=>"high burden of APC/PVC ( \\>15%): on wearable ECG monitoring"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Atrial Septal Defect", "Patent Foramen Ovale"]}, "descriptionModule"=>{"briefSummary"=>"This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale. Transthoracic echocardiography will be performed before the procedure, immediately after, and at 6, 18, 30 months after the procedure. Wearable ECG monitoring (\\> 3 days) will be performed before the procedure or immediately after procedure. Demographic, laboratory, hemodynamic data during procedure, and non-invasive imaging dat are obtained."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"19 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult ≥ 19 year-old\n* Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale\n* Patients provided with the written, informed consent to participate in this study\n\nExclusion Criteria:\n\n* Patients who had paroxysmal, persistent, or chronic AF\n* Life expectancy \\< 12 months\n* Subject who the investigator deems inappropriate to participate in this study"}, "identificationModule"=>{"nctId"=>"NCT06236776", "briefTitle"=>"AWARE Registry: Wearable ECG in Structural Heart Interventions", "organization"=>{"class"=>"OTHER", "fullName"=>"Yonsei University"}, "officialTitle"=>"Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry", "orgStudyIdInfo"=>{"id"=>"1-2023-0031"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"03722", "city"=>"Seoul", "country"=>"Korea, Republic of", "facility"=>"Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Iksung Cho", "role"=>"CONTACT", "email"=>"iksungcho@yuhs.ac", "phone"=>"82-2-2228-8442"}], "overallOfficials"=>[{"name"=>"Iksung Cho", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yonsei University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
