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
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Transcatheter Aortic Valve Replacement
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
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
NCT ID
NCT03600935
First Posted
July 4, 2018
Last Updated
September 24, 2018
Sponsor
BC Centre for Improved Cardiovascular Health
Collaborators
University of British Columbia
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
Learn more about this trial
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
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