Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT03600935
Status:
UNKNOWN
Last Update Posted:
2018-09-25
First Post:
2018-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 315}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Death or stroke', 'timeFrame': '1 year post-procedure'}], 'primaryOutcomes': [{'measure': 'The composite of all-cause mortality or stroke', 'timeFrame': '30 days post-procedure'}, {'measure': 'The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day', 'timeFrame': 'Discharge 1 day after procedure'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30 days post-procedure'}, {'measure': 'Stroke', 'timeFrame': '30 days post-procedure'}, {'measure': 'Major vascular complications', 'timeFrame': '30 days post-procedure'}, {'measure': 'Major/Life-threatening bleed', 'timeFrame': '30 days post-procedure'}, {'measure': 'Any hospital readmission', 'timeFrame': '30 days post-procedure'}, {'measure': '>mild paravalvular regurgiation', 'timeFrame': 'Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure'}, {'measure': 'New permanent pacemaker', 'timeFrame': '30 days post-procedure'}, {'measure': 'Patient is converted from local to general anaesthetic/receives intubation during procedure', 'timeFrame': 'This happens during the procedure'}, {'measure': 'Myocardial infarction', 'timeFrame': 'This happens during the procedure'}, {'measure': 'Repeat procedure for valve-related dysfunction', 'timeFrame': '30 days post-procedure'}, {'measure': 'Stage 3 acute kidney injury (need for dialysis)', 'timeFrame': '30 days post-procedure'}, {'measure': 'Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year', 'timeFrame': 'Baseline, and 30 days and 1 year post-procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter Aortic Valve Replacement'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve\n\n1. Considered at increased surgical risk by the Multidisciplinary Heart Team\n2. Informed written consent\n\nExclusion Criteria:\n\n1. Non-cardiovascular co-morbidity reducing life expectancy to \\<3 years\n2. Any factor precluding 1 year follow-up\n3. Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)\n4. Predicted inability to perform uncomplicated percutaneous vascular access and closure\n5. Illiofemoral diameter \\<6 mm (for 23 and 25 mm valves) and \\<6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head\n6. Surgical prosthesis \\<23 mm (labelled size) for valve-in-valve procedure\n7. In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)\n8. Language barriers (inability to understand peri-procedural and discharge instructions)\n9. Insufficient social support post procedure to allow next day discharge\n10. Airway unfavourable for emergent intubation\n11. Inability to lay supine without conscious sedation or general anaesthetic'}, 'identificationModule': {'nctId': 'NCT03600935', 'acronym': 'SAFETAVR', 'briefTitle': 'Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'BC Centre for Improved Cardiovascular Health'}, 'officialTitle': 'Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study', 'orgStudyIdInfo': {'id': 'TBD1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vancouver Clinical Pathway', 'description': 'The Vancouver Clinical Pathway utilizes objective anatomical and functional screening criteria as well as strict peri-procedural guidelines to determine if next day discharge home is appropriate.', 'interventionNames': ['Other: Vancouver Clinical Pathway']}], 'interventions': [{'name': 'Vancouver Clinical Pathway', 'type': 'OTHER', 'description': 'Vancouver Clinical Pathway', 'armGroupLabels': ['Vancouver Clinical Pathway']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David A Wood, MD', 'role': 'CONTACT', 'email': 'david.wood@vch.ca', 'phone': '6048755601'}, {'name': 'Shirley C Wong, PhD', 'role': 'CONTACT', 'email': 'safetavr@icvhealth.ubc.ca', 'phone': '6046822344', 'phoneExt': '65676'}], 'overallOfficials': [{'name': 'David A Wood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'John A Webb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BC Centre for Improved Cardiovascular Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of British Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}