NCT02287662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

November 6, 2014

Last Update Submit

July 4, 2018

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

  • The composite of all-cause mortality or stroke

    30 days post-procedure

  • The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day

    Next day

Secondary Outcomes (14)

  • All-cause mortality

    30 days post-procedure

  • Stroke

    30 days post-procedure

  • 30-day major vascular complications

    30 days post-procedure

  • 30-day major/life-threatening bleed

    30 days post-procedure

  • Any readmission to hospital within 30 days

    30 days post-procedure

  • +9 more secondary outcomes

Study Arms (1)

Vancouver 3M Clinical Pathway

EXPERIMENTAL

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

Vancouver 3M Clinical PathwayOTHER
Vancouver 3M Clinical Pathway

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36256698DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • David A Wood, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • John A Webb, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 11, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2017

Study Completion

May 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

CA(1)