Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
NCT ID: NCT03600935
Last Updated: 2018-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
315 participants
INTERVENTIONAL
2018-10-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vancouver Clinical Pathway
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.
Vancouver Clinical Pathway
Vancouver Clinical Pathway
Interventions
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Vancouver Clinical Pathway
Vancouver Clinical Pathway
Eligibility Criteria
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Inclusion Criteria
1. Considered at increased surgical risk by the Multidisciplinary Heart Team
2. Informed written consent
Exclusion Criteria
2. Any factor precluding 1 year follow-up
3. 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)
4. Predicted inability to perform uncomplicated percutaneous vascular access and closure
5. 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
6. Surgical prosthesis \<23 mm (labelled size) for valve-in-valve procedure
7. In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
8. Language barriers (inability to understand peri-procedural and discharge instructions)
9. Insufficient social support post procedure to allow next day discharge
10. Airway unfavourable for emergent intubation
11. Inability to lay supine without conscious sedation or general anaesthetic
ALL
No
Sponsors
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University of British Columbia
OTHER
BC Centre for Improved Cardiovascular Health
OTHER
Responsible Party
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Principal Investigators
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David A Wood, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
John A Webb, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Central Contacts
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Other Identifiers
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TBD1
Identifier Type: -
Identifier Source: org_study_id
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