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Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement (SAFETAVR)

Primary Purpose

Aortic Valve Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vancouver Clinical Pathway
Sponsored by
BC Centre for Improved Cardiovascular Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Transcatheter Aortic Valve Replacement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve

  1. Considered at increased surgical risk by the Multidisciplinary Heart Team
  2. Informed written consent

Exclusion Criteria:

  1. Non-cardiovascular co-morbidity reducing life expectancy to <3 years
  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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Vancouver Clinical Pathway

    Arm 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.

    Outcomes

    Primary Outcome Measures

    The composite of all-cause mortality or stroke
    The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day

    Secondary Outcome Measures

    All-cause mortality
    Stroke
    Major vascular complications
    Major/Life-threatening bleed
    Any hospital readmission
    >mild paravalvular regurgiation
    New permanent pacemaker
    Patient is converted from local to general anaesthetic/receives intubation during procedure
    Myocardial infarction
    Repeat procedure for valve-related dysfunction
    Stage 3 acute kidney injury (need for dialysis)
    Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year

    Full Information

    First Posted
    July 4, 2018
    Last Updated
    September 24, 2018
    Sponsor
    BC Centre for Improved Cardiovascular Health
    Collaborators
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03600935
    Brief Title
    Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
    Acronym
    SAFETAVR
    Official Title
    Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BC Centre for Improved Cardiovascular Health
    Collaborators
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Stenosis
    Keywords
    Transcatheter Aortic Valve Replacement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    315 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vancouver Clinical Pathway
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Vancouver Clinical Pathway
    Intervention Description
    Vancouver Clinical Pathway
    Primary Outcome Measure Information:
    Title
    The composite of all-cause mortality or stroke
    Time Frame
    30 days post-procedure
    Title
    The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day
    Time Frame
    Discharge 1 day after procedure
    Secondary Outcome Measure Information:
    Title
    All-cause mortality
    Time Frame
    30 days post-procedure
    Title
    Stroke
    Time Frame
    30 days post-procedure
    Title
    Major vascular complications
    Time Frame
    30 days post-procedure
    Title
    Major/Life-threatening bleed
    Time Frame
    30 days post-procedure
    Title
    Any hospital readmission
    Time Frame
    30 days post-procedure
    Title
    >mild paravalvular regurgiation
    Time Frame
    Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure
    Title
    New permanent pacemaker
    Time Frame
    30 days post-procedure
    Title
    Patient is converted from local to general anaesthetic/receives intubation during procedure
    Time Frame
    This happens during the procedure
    Title
    Myocardial infarction
    Time Frame
    This happens during the procedure
    Title
    Repeat procedure for valve-related dysfunction
    Time Frame
    30 days post-procedure
    Title
    Stage 3 acute kidney injury (need for dialysis)
    Time Frame
    30 days post-procedure
    Title
    Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year
    Time Frame
    Baseline, and 30 days and 1 year post-procedure
    Other Pre-specified Outcome Measures:
    Title
    Death or stroke
    Time Frame
    1 year post-procedure

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve Considered at increased surgical risk by the Multidisciplinary Heart Team Informed written consent Exclusion Criteria: Non-cardiovascular co-morbidity reducing life expectancy to <3 years Any factor precluding 1 year follow-up 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) Predicted inability to perform uncomplicated percutaneous vascular access and closure 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 Surgical prosthesis <23 mm (labelled size) for valve-in-valve procedure In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons) Language barriers (inability to understand peri-procedural and discharge instructions) Insufficient social support post procedure to allow next day discharge Airway unfavourable for emergent intubation Inability to lay supine without conscious sedation or general anaesthetic
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David A Wood, MD
    Phone
    6048755601
    Email
    david.wood@vch.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shirley C Wong, PhD
    Phone
    6046822344
    Ext
    65676
    Email
    safetavr@icvhealth.ubc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David A Wood, MD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John A Webb, MD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement

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