Status:
COMPLETED
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
Lead Sponsor:
BC Centre for Improved Cardiovascular Health
Collaborating Sponsors:
University of British Columbia
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver ...
Eligibility Criteria
Inclusion
- Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a balloon expandable transcatheter heart valve
- Considered at increased surgical risk by the Multidisciplinary Heart Team.
- Informed written consent
Exclusion
- 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
- Iliofemoral diameter \< 6 mm for SAPIEN XT or \<5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head)
- Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons.
- Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions
- MMSE \< 24/30 (unless language barrier or limited formal education), 5-metre gait \> 7 seconds (unless chronic mobility impairment not affecting ability to perform ADLs), and ADL \< 6/6
- Insufficient social support to facilitate next day discharge
- Airway unfavourable for emergent intubation
- Inability to lay supine without conscious sedation or general anesthetic
- Not receiving a balloon expandable transcatheter heart valve
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT02287662
Start Date
March 1 2015
End Date
May 1 2018
Last Update
July 6 2018
Active Locations (1)
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1
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6