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CompletedNCT022876623MTAVRUpdated Jul 6, 2018

The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement

An interventional study of Vancouver 3M Clinical Pathway in Aortic Valve Stenosis, sponsored by BC Centre for Improved Cardiovascular Health. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2018-07-06.

Sponsored by BC Centre for Improved Cardiovascular Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
411
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • Transcatheter Aortic Valve Replacement
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 411 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

BC Centre for Improved Cardiovascular Health is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Non -cardiovascular co-morbidity reducing 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. \< 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
411 participants (estimated)

Study arms

  • Experimental
    Vancouver 3M Clinical Pathway

    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.

    Other: Vancouver 3M Clinical Pathway

Interventions

  • OtherVancouver 3M Clinical Pathway
06

What researchers measure

Primary outcomes

  1. The composite of all-cause mortality or stroke

    Time frame: 30 days post-procedure

  2. 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 outcomes

  1. All-cause mortality

    Time frame: 30 days post-procedure

  2. Stroke

    Time frame: 30 days post-procedure

  3. 30-day major vascular complications

    Time frame: 30 days post-procedure

  4. 30-day major/life-threatening bleed

    Time frame: 30 days post-procedure

  5. Any readmission to hospital within 30 days

    Time frame: 30 days post-procedure

  6. > mild paravalvular regurgitation

    Time frame: Post-procedure/discharge

  7. New permanent pacemaker

    Time frame: 30 days post-procedure

  8. Conversion to general anesthetic/intubation

    Time frame: Peri-procedure

  9. Myocardial infarction

    Time frame: Peri-procedure

  10. Repeat procedure for valve-related dysfunction

    Time frame: 30 days post-procedure

  11. Stage 3 acute kidney injury (need for dialysis)

    Time frame: 30 days post-procedure

  12. 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

  13. Economic evaluation including health resource utilization, and cost effectiveness

    Time frame: Peri- and post-procedure

  14. Death or stroke at one year

    Time frame: 1 year post-procedure

07

Study locations

1 site
  • St Paul's Hospital
    Vancouver, British Columbia V6Z1Y6, Canada
08

References and documents

Publications

  • 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. PubMed 36256698 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02287662
Lead sponsor
BC Centre for Improved Cardiovascular Health
Collaborators
University of British Columbia
Responsible party
Sponsor
First posted
Nov 11, 2014
Start date
Mar 2015
Primary completion
Apr 2017
Completion
May 2018
Last update
Jul 6, 2018

Study contacts

David A Wood, MD
principal investigator · University of British Columbia
John A Webb, MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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