Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:32 AM
Study NCT ID:
NCT07421557
Status:
AVAILABLE
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access of Occlutech's Atrial Flow Regulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}}, 'descriptionModule': {'briefSummary': "Occlutech AFR use allowed per FDA's Expanded Access program.", 'detailedDescription': "Occlutech AFR use allowed per FDA's Expanded Access program. Each individual request is sent for FDA approval and the site's IRB approval per regulations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07421557', 'briefTitle': "Expanded Access of Occlutech's Atrial Flow Regulator", 'organization': {'class': 'INDUSTRY', 'fullName': 'Occlutech International AB'}, 'orgStudyIdInfo': {'id': 'AFR Expanded Access'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Catheter implantation of Occlutech AFR device', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55369', 'city': 'Maple Grove', 'state': 'Minnesota', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Individual Sites Across the U.S.', 'geoPoint': {'lat': 45.07246, 'lon': -93.45579}}], 'centralContacts': [{'name': 'Ramona Ruble', 'role': 'CONTACT', 'email': 'ramona.ruble@occlutech.com', 'phone': '6126449990'}, {'name': 'Distribution List Distribution List', 'role': 'CONTACT', 'email': 'physician.requests@occlutech.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Occlutech International AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}