Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-05 @ 9:11 PM
Study NCT ID:
NCT02255851
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel(TM) Post-Market Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Capture and histopathology analysis of embolic debris. (Thrombus, valve tissue, amorphous calcium, etc.)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-22', 'studyFirstSubmitDate': '2014-09-25', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Observational Endpoint', 'timeFrame': 'Post-Procedure (day 1)', 'description': 'Capture rate, debris volume and histopathology analysis at day 1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['selected for TAVR by heart team consensus', 'treated with CE-Marked TAVR devices'], 'conditions': ['Transcatheter Aortic Valve Replacement', 'Severe Symptomatic Calcified Native Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.\n\nSubjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.\n\nAll Sentinel filters will be sent for histopathology at an independent core-lab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The registry population comprises subjects with severe symptomatic calcified native aortic valve stenosis who are selected for TAVR by heart team consensus and treated with CE-Marked TAVR devices.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Approved indications for commercially available CE-Marked TAVR devices.\n2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\\> 70%).\n3. The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.\n\nExclusion Criteria:\n\n1. Vasculature in the right extremity precluding 6Fr sheath radial/brachial access\n2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse\n3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature\n4. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion\n5. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion\n6. Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium\n7. Currently participating in an investigational drug or investigational (non CE-mark) device study"}, 'identificationModule': {'nctId': 'NCT02255851', 'briefTitle': 'Sentinel(TM) Post-Market Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Claret Medical'}, 'officialTitle': 'Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement', 'orgStudyIdInfo': {'id': 'CP10879'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Group', 'description': 'TAVR + SENTINEL (Cerebral Protection System)', 'interventionNames': ['Device: SENTINEL (Cerebral Protection System)']}], 'interventions': [{'name': 'SENTINEL (Cerebral Protection System)', 'type': 'DEVICE', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christoph Naber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elisabeth-Krankenhaus Essen GmbH, Essen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claret Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}