Back to resultsThe Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement (3MTAVR)
Primary Purpose
Aortic Valve Stenosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vancouver 3M 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 balloon expandable 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
- 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
Sites / Locations
- St Paul's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vancouver 3M Clinical Pathway
Arm 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.
Outcomes
Primary Outcome Measures
The composite of all-cause mortality or stroke
The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day
Secondary Outcome Measures
All-cause mortality
Stroke
30-day major vascular complications
30-day major/life-threatening bleed
Any readmission to hospital within 30 days
> mild paravalvular regurgitation
New permanent pacemaker
Conversion to general anesthetic/intubation
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 and SF-12 at baseline, 2 weeks, 30 days, and 1 year
Economic evaluation including health resource utilization, and cost effectiveness
Death or stroke at one year
Full Information
NCT ID
NCT02287662
First Posted
November 6, 2014
Last Updated
July 4, 2018
Sponsor
BC Centre for Improved Cardiovascular Health
Collaborators
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02287662
Brief Title
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
Acronym
3MTAVR
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2018 (Actual)
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
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 balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.
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
411 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vancouver 3M Clinical Pathway
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Vancouver 3M 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 3M Clinical Pathway, who are discharged the next day
Time Frame
Next day
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
30 days post-procedure
Title
Stroke
Time Frame
30 days post-procedure
Title
30-day major vascular complications
Time Frame
30 days post-procedure
Title
30-day major/life-threatening bleed
Time Frame
30 days post-procedure
Title
Any readmission to hospital within 30 days
Time Frame
30 days post-procedure
Title
> mild paravalvular regurgitation
Time Frame
Post-procedure/discharge
Title
New permanent pacemaker
Time Frame
30 days post-procedure
Title
Conversion to general anesthetic/intubation
Time Frame
Peri-procedure
Title
Myocardial infarction
Time Frame
Peri-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 and SF-12 at baseline, 2 weeks, 30 days, and 1 year
Time Frame
Baseline, and 2 weeks, 30 day and 1 year post procedure
Title
Economic evaluation including health resource utilization, and cost effectiveness
Time Frame
Peri- and post-procedure
Title
Death or stroke at one year
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 balloon expandable 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
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
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
Facility Information:
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
36256698
Citation
Butala NM, Wood DA, Li H, Chinnakondepalli K, Lauck SB, Sathananthan J, Cairns JA, Magnuson EA, Barker M, Webb JG, Welsh R, Cheung A, Ye J, Velianou JL, Wijeysundera HC, Asgar A, Kodali S, Thourani VH, Cohen DJ; 3M-TAVR Investigators. Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study. Circ Cardiovasc Interv. 2022 Oct;15(10):e012168. doi: 10.1161/CIRCINTERVENTIONS.122.012168. Epub 2022 Oct 18.
Results Reference
derived
Learn more about this trial
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
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