Skip to main content
OpenTrials
Completed

NCT Number: NCT02287662

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancouver 3M Clinical Pathway

Other

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

Sponsors and collaborators

Lead sponsor

BC Centre for Improved Cardiovascular Health

Other

Collaborators

  • University of British Columbia

Registry information

Official study 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

Acronym: 3MTAVR

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 11, 2014
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.