Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-25 @ 2:59 AM
Study NCT ID:
NCT06465459
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Clinical Study of the LAMBRE System for Left Auricle 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': 'ESTIMATED', 'count': 220}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device.', 'timeFrame': 'during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device', 'description': 'the occurrence of one of the following events: ischaemic stroke, systemic embolism, rate of device migration and death of cardiovascular or unexplained origin occurring in patients implanted with a left atrial closure device.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'end of procedure', 'description': 'The success rate of the procedure at the end of implantation'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 3 months after implantation', 'description': 'the results of the scanner and/or transesophageal ultrasound concerning the rate of occlusion of the left auricle'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 3 months after implantation', 'description': 'the positioning of the prosthesis'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 3 months after implantation', 'description': 'the rate of periprosthetic shunts on the atrial side of the prosthesis'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 3 months after implantation', 'description': 'the rate of periprosthetic thrombus on the atrial side of the prosthesis'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 1 year after implantation', 'description': 'The rate of ischemic stroke'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 1 year after implantation', 'description': 'The rate of TIA'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 1 year after implantation', 'description': 'The rate of systemic embolism'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 1 year after implantation', 'description': 'The rate of death of cardiovascular or unexplained origin'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 1 year after implantation', 'description': 'The rate of death'}, {'measure': 'To evaluate the effectiveness of the device', 'timeFrame': 'at 1 year after implantation', 'description': 'The comparison of the frequency of ischemic cerebral or systemic accidents to the theoretical predicted value'}, {'measure': 'To evaluate the tolerance of the procedure and the device', 'timeFrame': 'at the pre-discharge examination (up to 3 days)', 'description': 'Complications linked or potentially linked to the implantation procedure or the device, percentage of device migration or pericardial effusion by trans-thoracic or trans-esophageal ultrasound'}, {'measure': 'To evaluate the tolerance of the procedure and the device', 'timeFrame': 'at 3 months', 'description': 'percentage of thrombosis on prosthesis or migration of the prosthesis by scanner and/or in the absence of trans-esophageal ultrasound'}, {'measure': 'To evaluate the tolerance of the procedure and the device', 'timeFrame': 'at 1 year', 'description': 'Percentage of major and/or life-threatening bleeding complications and total percentage of complications related or potentially related to the procedure or device'}, {'measure': 'Description of bleeding complications not related to the device or procedure', 'timeFrame': 'during procedure and a follow-up lasting 12 months in a population having had a inmplantation of an Lambre device', 'description': 'Percentage of patients who experienced at least one bleeding complication unrelated to the device or procedure during the entire study'}, {'measure': 'Description of the population and centers', 'timeFrame': 'at baseline', 'description': 'demographic and clinical characteristics of patients'}, {'measure': 'Description of antithrombotic treatments prescribed following implantation of the device', 'timeFrame': 'at inclusion, at the pre-discharge examination (up to 3 days), at 30 days, 3 months and 12 months after implantation', 'description': 'Percentage of patients on injectable or oral anticoagulants and on antiplatelet agents at the different follow-up times, Percentage of patients on injectable or oral anticoagulants at different follow-up times, Percentage of patients on antiplatelet agents in mono or dual therapy at the different follow-up times, Average duration of anticoagulant and antiplatelet treatments.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-valvular atrial fibrillation', 'atrial fibrillation', 'LAMBRE system'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is responsible for 15-20% of ischaemic strokes. These events are often caused by thrombus formation in the left atrium. Thromboembolic risk in AF is primarily prevented by oral anticoagulation. However, this drug-based approach has a number of limitations, the most important of which are compliance problems and, above all, the risk of haemorrhagic complications, some of which are potentially serious. Left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated.\n\nThe CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE, LIFETCH prosthesis, a device for transcatheter closure of the left atrial appendage, is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score ≥ 4 and a formal and permanent contraindication to anticoagulants (validated by a multidisciplinary committee).\n\nLAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee. Among the criteria analysed regarding the efficacy and safety of the device implantation, the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be included in cardiology departments participating in the study. Non-valvular atrial fibrillation patients at high cardio-embolic risk, contraindicated to anticoagulants, scheduled for percutaneous left atrial closure with implantation of the Lambre device will be included in the protocol and monitored as part of their care by the centers that performed the procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requiring a left atrial exclusion procedure according to the recommendations by the CNEDiMTS and HAS using the LAMBRE device\n* Age ≥18 years\n* Patient has been informed of the nature of the study and agrees to participate\n\nExclusion Criteria:\n\n* Minor patient\n* Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)'}, 'identificationModule': {'nctId': 'NCT06465459', 'acronym': 'ESCALLE', 'briefTitle': 'Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure', 'orgStudyIdInfo': {'id': '2024-A00420-47'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients scheduled for percutaneous left atrial closure with Lambre device implantation.', 'interventionNames': ['Procedure: LAMBRE device implantation']}], 'interventions': [{'name': 'LAMBRE device implantation', 'type': 'PROCEDURE', 'description': 'LAMBRE device implantation', 'armGroupLabels': ['Patients scheduled for percutaneous left atrial closure with Lambre device implantation.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33600', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier IRIART', 'role': 'CONTACT', 'email': 'xavier.iriart@chu-bordeaux.fr', 'phone': '(+33) 5.57.65.64.65'}], 'facility': 'Hôpital Cardiologique de Haut Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'centralContacts': [{'name': 'Xavier IRIART', 'role': 'CONTACT', 'email': 'xavier.iriart@chu-bordeaux.fr', 'phone': '(+33) 5.57.65.64.65'}], 'overallOfficials': [{'name': 'Xavier IRIART', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Cardiologique de Haut Lévêque'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lifetech Scientific (Shenzhen) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}