Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 6:50 PM
Study NCT ID:
NCT01628068
Status:
UNKNOWN
Last Update Posted:
2012-06-26
First Post:
2012-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2012-06-22', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined overall mortality, major bleeding, stroke or procedure-related complications', 'timeFrame': '1 year', 'description': 'The primary end point will be at one year the combined overall mortality, major bleeding, stroke or procedure-related complications.\n\n1. Mortality from any cause\n2. Severe bleeding defined according to VARC criteria\n3. Ischemic stroke or hemorrhagic stroke at 12 months.\n4. Complications related to the procedure: include:\n\n * device embolization\n * severe pericardial effusion with hemodynamic compromise that requires drainage\n * Device thrombosis\n * cardiac perforation\n * major local complications (according to definitions of VARC)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Left atrial appendage occlusion', 'gastrointestinal bleeding'], 'conditions': ['Adverse Reaction to Drugs Affecting the Gastrointestinal System']}, 'descriptionModule': {'briefSummary': 'Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial fibrillation without associated valvular heart disease, to reduce significantly the risk of stroke while minimizing the risk of bleeding in a group of patients with high risk for both events.\n\nELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of atrial appendage left versus standard treatment with oral anticoagulants in patients with history of gastrointestinal bleeding and high embolic risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease\n* \\> 18 years\n* Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants\n* CHA2-DS2-VASC score ≥ 3\n* prior digestive bleeding without any treatable cause\n* Informed consent.\n\nExclusion Criteria:\n\n* POF\n* contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel)\n* Intracardiac thrombus\n* significant carotid disease\n* Cardioversion scheduled within 30 days following the implantation\n* AF not controlled by FVM\\> 100 bpm\n* AF secondary to surgery or ablation\n* thrombosis in patients \\<40 years\n* chronic renal insufficiency with Cr clearance \\<30 ml 2\n* left appendage sizeappendage with inlet \\<12.6 mm or \\> 28.5 (ETE)\n* depth of the appendage \\<10mm in the TEE'}, 'identificationModule': {'nctId': 'NCT01628068', 'acronym': 'ELIGIBLE', 'briefTitle': 'ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding', 'orgStudyIdInfo': {'id': 'ELIGIBLE'}, 'secondaryIdInfos': [{'id': 'Estudio ELIGIBLE', 'type': 'OTHER', 'domain': 'Fundació Clínic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Left atrial appendage occlusion', 'description': 'Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months', 'interventionNames': ['Device: Left atrial appendage occlusion']}, {'type': 'NO_INTERVENTION', 'label': 'Oral anticoagulation', 'description': 'Oral anticoagulation'}], 'interventions': [{'name': 'Left atrial appendage occlusion', 'type': 'DEVICE', 'description': 'Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months', 'armGroupLabels': ['Left atrial appendage occlusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06006', 'city': 'Badajoz', 'state': 'Badajoz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Ramón López Mínguez, MD, PhD', 'role': 'CONTACT', 'email': 'lópez-mínguez@hotmail.com', 'phone': '+34-924218100'}, {'name': 'José Ramón López Mínguez, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Victoria Martín Yuste, MD, PhD', 'role': 'CONTACT', 'email': 'vmartiny@clinic.ub.es', 'phone': '+34-932275400'}, {'name': 'Victoria Martín Yuste, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manel Sabaté Tenas, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fundació Clínic per a la Recerca Biomèdica', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raúl Moreno, MD, PhD', 'role': 'CONTACT'}, {'name': 'Raúl Moreno, MD,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Mdrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Goicolea, MD', 'role': 'CONTACT'}, {'name': 'Javier Goicolea, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'José Antonio Fernández Díaz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'state': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José María Hernández García, MD', 'role': 'CONTACT'}, {'name': 'José María Hernández García, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'state': 'Sevilla', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael Ruiz Salmerón, MD', 'role': 'CONTACT'}, {'name': 'Rafael Ruiz Salmerón, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Virgen de la Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Victoria Martín Yuste, MD, PhD', 'role': 'CONTACT', 'email': 'vmartiny@clinic.ub.es', 'phone': '+34-93-227-55-19'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Victoria Martin Yuste', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}