Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 8:01 PM
Study NCT ID:
NCT05369195
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2022-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'In order to blind the radial artery will also be punctured in control group and an aortography will be performed. Researchers participating in the randomization of patients and in the procedure will not be included in the remaining stages of the study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2022-03-15', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of silent cerebral ischemia (SBI) foci', 'timeFrame': 'change in the period up to 24 months', 'description': 'number of SBI foci in DW MRI of the brain'}, {'measure': 'Change in volume of silent cerebral ischemia (SBI) foci', 'timeFrame': 'change in the period up to 24 months', 'description': 'volume SBI foci in DW MRI of the brain'}], 'secondaryOutcomes': [{'measure': 'Deterioration of cognitive functions', 'timeFrame': 'prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months', 'description': 'Montreal Cognitive Assessment (MoCA) test (scoring 0-30; cut-off value \\<26)'}, {'measure': 'Deterioration of cognitive functions', 'timeFrame': 'prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months', 'description': 'The Trail Making Test Part A and B for Dementia (TMT A\\&B) - incorrect values: for part A \\> 70 sec. and for part B\\> 273 sec.'}, {'measure': 'Development of dementia', 'timeFrame': 'prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months', 'description': 'diagnosis made by a specialist neurologist'}, {'measure': 'Occurrence of depressive disorders', 'timeFrame': 'prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months', 'description': 'Hemiltona depression scale - 0 to 50 point, the higher the score, the more severe the mood disorder'}, {'measure': 'Presence of embolic material in the filters of the neuroprotection device', 'timeFrame': 'during LAAC procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral protection', 'left atrial appendage occlusion', 'atrial fibrillation', 'silent brain ischemia', 'cognitive impairment', 'depression'], 'conditions': ['Atrial Fibrillation', 'Silent Stroke', 'Cognitive Impairment', 'Depression']}, 'referencesModule': {'references': [{'pmid': '37996955', 'type': 'DERIVED', 'citation': 'Streb W, Lasek-Bal A, Mitrega K, Kowalczyk J, Podolecki T, Kowalska W, Olma A, Sobczyk A, Kalarus Z. Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial. Trials. 2023 Nov 23;24(1):749. doi: 10.1186/s13063-023-07766-3.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated cognitive impairment and depression.', 'detailedDescription': 'Introduction: Left atrial appendage occlusion (LAAC) procedure is a method of preventing stroke in patients with atrial fibrillation who cannot use anticoagulants. The number of patients undergoing LAAC treatment tends to increase. LAAC procedures effectively reduce the number of strokes, with a significant reduction in the risk of bleeding compared to oral anticoagulants. However, although LAAC treatments alone have a low risk of perioperative stroke, some patients may experience incidents of silent brain ischemia (SBI). The distant effect of SBI may be cognitive deterioration, the onset of dementia syndromes, as well as depression.\n\nPurpose of the study: The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage (LAAC) in patients with atrial fibrillation on the risk of perioperative SBI and associated cognitive impairment and depression.\n\nMethodology: The planned study is a prospective, multicentre, randomized, and double-blind intervention trial. Neuroprotection introduced from arterial access will be used in the LAAC treatment study group. In the control group, LAAC treatments will be performed without neuroprotection. Two hundred forty patients are planned to be enrolled with indications for stroke prevention due to atrial fibrillation. The analysis will include data obtained from DW MRI images, neurological evaluation results along with NIHSS-scale scores, results of cognitive evaluation tests (MoCA, COWAT, TMT A\\&B), and test of mood disorders (HADS Scale), as well as results of the EQ-5D-5L quality of life assessment questionnaire. It is planned to observe patients participating in the study for 24 months after LAAC procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 Years and older\n2. Subject able to provide signed informed consent.\n3. Documented permanent, persistent, or paroxysmal atrial fibrillation\n4. CHA2DS2VASc risk of stroke ≥2\n5. At least one of the following criteria:\n\n 1. Contraindications to the use of anticoagulants,\n 2. HSBLED bleeding risk ≥3\n\nExclusion Criteria:\n\n1. Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder\n2. History of ischemic stroke\n3. Chronic abuse of alcohol or any other psychoactive substances except for nicotine\n4. long-term therapy with benzodiazepines\n5. The use of antidepressants in 3 months prior inclusion.\n6. Previous infections of the central nervous system, including neuroborreliosis\n7. Parkinson's disease\n8. Huntington's chorea\n9. Creutzfeld-Jakob disease\n10. Pick's disease\n11. Significant atherosclerosis of the cephalic arteries (\\> 70% LCCA or the brachiocephalic trunk)\n12. Strictures, ectasias, dissection or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above\n13. Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale\n14. Presence of a thrombus or tumours of a different nature in the left atrium or its ear\n15. Presence of a thrombus in the left ventricle\n16. Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage\n17. The presence of mechanical heart valve prostheses\n18. The state after the operative closure of the defect in the atrial septum\n19. Condition after closing the defect in the interatrial septum with the use of occluders\n20. Active infective endocarditis\n21. Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS)\n22. Status after oesophagal surgery\n23. Esophageal diverticula\n24. Esophageal varices\\> grade 3\n25. Allergic to contrast agents\n26. A contraindication to use antiplatelet drugs\n27. Diagnosis of neoplastic disease with estimated survival beyond 1 year\n28. Clininally evident hypothyroidism and hyperthyroidism\n29. Klaustrofobia\n30. Pregnancy\n31. AIDS\n32. Participation in other drug research studies\n33. The presence of circumstances or any medical condition the Investigator considers problematic for subject inclusion, or test results that may couse problems to provide reliable, acurate to interpretation results"}, 'identificationModule': {'nctId': 'NCT05369195', 'acronym': 'LAAC-SBI', 'briefTitle': 'Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Silesian Centre for Heart Diseases'}, 'officialTitle': 'Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'LAAC-SBI ver. 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAAC with neuroprotection', 'description': 'Arm in which is used a transcatheter system to protect the cerebral circulation during the left atrial appendage closure procedures.', 'interventionNames': ['Procedure: LAAC procedure with the use of transcatheter cerebral protection system']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LAAC without neuroprotection', 'description': 'Arm in which the left atrial appendage closure procedures are performed without transcatheter cerebral protection.', 'interventionNames': ['Procedure: LAAC procedure without the use of transcatheter cerebral protection system']}], 'interventions': [{'name': 'LAAC procedure with the use of transcatheter cerebral protection system', 'type': 'PROCEDURE', 'description': 'After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.', 'armGroupLabels': ['LAAC with neuroprotection']}, {'name': 'LAAC procedure without the use of transcatheter cerebral protection system', 'type': 'PROCEDURE', 'description': 'Only the aortography through radial access will be done before accessing the left atrium.', 'armGroupLabels': ['LAAC without neuroprotection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40-635', 'city': 'Katowice', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Klaudia Rogowska', 'role': 'CONTACT', 'email': 'dyrektor@gcm.pl', 'phone': '+48 32 3598313'}, {'name': 'Wojciech Wojakowski, Prof.', 'role': 'CONTACT', 'email': 'wwojakowski@sum.edu.pl', 'phone': '+48 32 252 39 30'}, {'name': 'Wojciech Wojakowski, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-202', 'city': 'Krakow', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Tadeusz Przewłocki, Prof.', 'role': 'CONTACT', 'email': 'tadeuszprzewlocki@op.pl'}, {'name': 'Tadeusz Przewłocki, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '61-848', 'city': 'Poznan', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marek Grygier, Prof.', 'role': 'CONTACT', 'email': 'marek.grygier@skpp.edu.pl'}, {'name': 'Marek Grygier', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '04-141', 'city': 'Warsaw', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Piotr Kwiatkowski, MD', 'role': 'CONTACT', 'email': 'pkwiatkowski@wim.mil.pl'}, {'name': 'Piotr Kwiatkowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-625', 'city': 'Warsaw', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marcin Demkow, Prof.', 'role': 'CONTACT', 'email': 'm.demkow@ikard.pl'}, {'name': 'Marcin Demkow, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '41-800', 'city': 'Zabrze', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Witold Streb, Ph.D', 'role': 'CONTACT', 'email': 'w.streb@sccs.pl', 'phone': '+48 32 2713414'}, {'name': 'Zbigniew Kalarus, Prof.', 'role': 'CONTACT', 'email': 'karzab@sum.edu.pl', 'phone': '+48 32 37 33 682'}, {'name': 'Zbigniew Kalarus, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Witold Streb, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katarzyna Mitręga, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wiktoria Kowalska, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Monika Kozioł, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tomasz Podolecki, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agata Sobczyk, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Silesian Centre for HEart Diseases in Zabrze', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'centralContacts': [{'name': 'Witold A Streb, Ph.D.', 'role': 'CONTACT', 'email': 'w.streb@sccs.pl', 'phone': '0048322713414'}], 'overallOfficials': [{'name': 'Zbigniew F Kalarus, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Silesian Centre for Heart Diseases in Zabrze'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silesian Centre for Heart Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leszek Giec Upper-Silesian Medical Centre', 'class': 'UNKNOWN'}, {'name': 'Medical University of Silesia', 'class': 'OTHER'}, {'name': 'Biostat Sp. z o.o.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}