Brief Title
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
Official Title
Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study
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.
Study Type
Interventional
Primary Outcome
The composite of all-cause mortality or stroke
Secondary Outcome
All-cause mortality
Condition
Aortic Valve Stenosis
Intervention
Vancouver Clinical Pathway
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
315
Start Date
October 2018
Completion Date
September 2021
Primary Completion Date
September 2020
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David A Wood, MD, 6048755601, [email protected]
Administrative Informations
NCT ID
NCT03600935
Organization ID
TBD1
Responsible Party
Sponsor
Study Sponsor
BC Centre for Improved Cardiovascular Health
Collaborators
University of British Columbia
Study Sponsor
David A Wood, MD, Principal Investigator, University of British Columbia
Verification Date
July 2018