Brief Title
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
Official Title
The Vancouver Multidisciplinary, Multimodality, But Minimalist Clinical Pathway Facilitates Safe Next Day Discharge Home at Low, Medium, and High Volume Transfemoral Transcatheter Aortic Valve Replacement Centres: The 3M 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 balloon-expandable transfemoral TAVR utilizing
the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.
Study Type
Interventional
Primary Outcome
The composite of all-cause mortality or stroke
Secondary Outcome
All-cause mortality
Condition
Aortic Valve Stenosis
Intervention
Vancouver 3M Clinical Pathway
Study Arms / Comparison Groups
Vancouver 3M Clinical Pathway
Description: The Vancouver 3M 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
411
Start Date
March 2015
Completion Date
May 2018
Primary Completion Date
April 2017
Eligibility Criteria
Inclusion Criteria:
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with
a balloon expandable 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. Iliofemoral diameter < 6 mm for SAPIEN XT or <5.5 mm for SAPIEN 3 (measured at or
above the mid-femoral head)
6. Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital
for logistical reasons.
7. Significant communication barrier(s) that interfere with ability to follow
peri-procedural and discharge instructions
8. 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
9. Insufficient social support to facilitate next day discharge
10. Airway unfavourable for emergent intubation
11. Inability to lay supine without conscious sedation or general anesthetic
12. Not receiving a balloon expandable transcatheter heart valve
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David A Wood, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02287662
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