Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-28 @ 1:34 PM
Study NCT ID:
NCT04683692
Status:
WITHDRAWN
Last Update Posted:
2023-04-14
First Post:
2020-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'For both the parent study and the sub-study, participants and investigators will be unblinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parent Study Design: Patients undergoing clinically indicated catheter ablation for AF in the parent study will be randomized 2:1 to two arms: (1) cerebral protection with the Sentinel device and (2) control group without cerebral protection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This sub-study was combined to the parent study protocol (NCT04685317)', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New cerebral infarcts', 'timeFrame': 'day 1 to 7 after atrial fibrillation ablation', 'description': 'Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group'}, {'measure': 'Change in high sensitivity CRP (hs-CRP)', 'timeFrame': 'baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation', 'description': 'High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation'}, {'measure': 'Change in interleukin-6 (IL-6)', 'timeFrame': 'baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation', 'description': 'Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation'}, {'measure': 'Change in NT-proBNP', 'timeFrame': 'baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation', 'description': 'NT-proBNP measured in pg/ml to detect changes in tissue damage'}, {'measure': 'Change in high sensitivity troponin', 'timeFrame': 'baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation', 'description': 'High sensitivity troponin measure in ng/mL to detect changes in tissue damage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.', 'detailedDescription': 'Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included\n\nExclusion Criteria:\n\n* Severe peripheral arterial disease that precludes deployment of Sentinel device\n* Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device\n* Unable or unwilling to provide informed consent.\n* Known history of dementia.'}, 'identificationModule': {'nctId': 'NCT04683692', 'briefTitle': 'A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study', 'orgStudyIdInfo': {'id': '20-001308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cerebral protection with the Sentinel device', 'description': 'Subjects who received the Sentinel device in the parent study', 'interventionNames': ['Device: Magnetic Resonance Imaging (MRI)', 'Other: Laboratory Testing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group without cerebral protection', 'description': 'Subjects who did not received the Sentinel device in the parent study', 'interventionNames': ['Device: Magnetic Resonance Imaging (MRI)', 'Other: Laboratory Testing']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'DEVICE', 'description': 'Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation', 'armGroupLabels': ['Cerebral protection with the Sentinel device', 'Control group without cerebral protection']}, {'name': 'Laboratory Testing', 'type': 'OTHER', 'description': 'Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation', 'armGroupLabels': ['Cerebral protection with the Sentinel device', 'Control group without cerebral protection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ammar Killu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ammar M. Killu', 'investigatorAffiliation': 'Mayo Clinic'}}}}