Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-26 @ 11:33 AM
Study NCT ID:
NCT04240366
Status:
RECRUITING
Last Update Posted:
2024-08-29
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2020-01-23', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time until any documented episode of ATa', 'timeFrame': '3 - 12 months', 'description': 'Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Persistent or Long-standing Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.', 'detailedDescription': 'The intervention in the LALA-LAND-AF trial is the additional LAAI in patients with catheter ablation for persistent AF and will be performed once as index ablation as outlined above. With exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for AF as stated by the European Society of Cardiology (ESC) 11,18 and an expert consensus statement on catheter and surgical ablation1. Patients may be treated with a specific antiarrhythmic drug (AAD) for a maximum of 3 months following the index ablation. No repeat ablation for AF should be performed within the first 3 months. Thereafter, repeat ablations are permitted for recurrent AF irrespective of group allocation. Ablation strategy at repeat ablation includes PV re-isolation if required in both groups and re-isolation of the LAA in the intervention group. In the control group, LAAI may only be performed in case all PV were isolated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \\>7 days or \\>12 months, respectively)\n2. Age ≥18 and ≤80 years\n3. Indication for AF ablation as per current guidelines\n\nExclusion Criteria:\n\n1. Missing informed consent\n2. LAA diameter \\>25mm 10mm distant from circumflex artery assessed by TEE\n3. Paroxysmal atrial fibrillation\n4. Long-standing persistent atrial fibrillation with a continuous AF duration of \\>4 years\n5. Previous pulmonary vein isolation or MAZE surgery\n6. Previous led atrial appendage closure or surgical excision\n7. Left atrial diameter \\>60 mm at baseline\n8. Left atrial thrombus at baseline'}, 'identificationModule': {'nctId': 'NCT04240366', 'acronym': 'LALA-LAND-AF', 'briefTitle': 'Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': '19-323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone', 'interventionNames': ['Procedure: Control intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation', 'interventionNames': ['Procedure: Experimental intervention']}], 'interventions': [{'name': 'Control intervention', 'type': 'PROCEDURE', 'otherNames': ['Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone'], 'description': 'patients treated with balloon-based ablation of AF by PVI', 'armGroupLabels': ['Group 1']}, {'name': 'Experimental intervention', 'type': 'PROCEDURE', 'otherNames': ['Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation'], 'description': 'patients treated with balloon-based ablation of AF by PVI', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20251', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Metzner, Prof. Dr.', 'role': 'CONTACT', 'email': 'a.metzner@uke.de', 'phone': '0049407410', 'phoneExt': '58320'}], 'facility': 'University Hospital Eppendorf, Hamburg, Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22763', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian H. Heeger, Prof. Dr.', 'role': 'CONTACT', 'email': 'c.heeger@asklepios.com', 'phone': '004940181881', 'phoneExt': '1221'}], 'facility': 'Asklepios Klinik Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Roland Tilz, Prof. Dr.', 'role': 'CONTACT', 'email': 'roland.tilz@uksh.de', 'phone': '0049451500', 'phoneExt': '44511'}, {'name': 'Charlotte Eitel, Prof. Dr.', 'role': 'CONTACT', 'email': 'charlotte.eitel@uksh.de', 'phone': '0049451500', 'phoneExt': '44511'}], 'facility': 'Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'centralContacts': [{'name': 'Roland Tilz, Prof. Dr.', 'role': 'CONTACT', 'email': 'roland.tilz@uksh.de', 'phone': '+49451500', 'phoneExt': '44672'}, {'name': 'Charlotte Eitel, Prof. Dr.', 'role': 'CONTACT', 'email': 'charlotte.eitel@uksh.de', 'phone': '+49451500', 'phoneExt': '44672'}], 'overallOfficials': [{'name': 'Roland R. Tilz, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie'}, {'name': 'Sorin S. Popescu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'collaborators': [{'name': 'IHF GmbH - Institut für Herzinfarktforschung', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Electrophysiology Department', 'investigatorFullName': 'Roland Richard Tilz, MD', 'investigatorAffiliation': 'University of Luebeck'}}}}