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Status unknownNCT03600935SAFETAVRUpdated Sep 25, 2018

Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement

An interventional study of Vancouver Clinical Pathway in Aortic Valve Stenosis, sponsored by BC Centre for Improved Cardiovascular Health. Status unknown. Per ClinicalTrials.gov, last updated 2018-09-25.

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

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
315
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 self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.

02

Conditions studied

  • Aortic Valve Stenosis

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Keywords

  • Transcatheter Aortic Valve Replacement
03

Who can participate

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

Inclusion criteria

Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding 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 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. Illiofemoral diameter \<6 mm (for 23 and 25 mm valves) and \<6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head
  6. Surgical prosthesis \<23 mm (labelled size) for valve-in-valve procedure
  7. In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
  8. Language barriers (inability to understand peri-procedural and discharge instructions)
  9. Insufficient social support post procedure to allow next day discharge
  10. Airway unfavourable for emergent intubation
  11. Inability to lay supine without conscious sedation or general anaesthetic
04

Study design

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

Study arms

  • Experimental
    Vancouver Clinical Pathway

    The Vancouver 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 Clinical Pathway

Interventions

  • OtherVancouver Clinical Pathway

    Vancouver Clinical Pathway

05

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 Clinical Pathway, who are discharged the next day

    Time frame: Discharge 1 day after procedure

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days post-procedure

  2. Stroke

    Time frame: 30 days post-procedure

  3. Major vascular complications

    Time frame: 30 days post-procedure

  4. Major/Life-threatening bleed

    Time frame: 30 days post-procedure

  5. Any hospital readmission

    Time frame: 30 days post-procedure

  6. >mild paravalvular regurgiation

    Time frame: Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure

  7. New permanent pacemaker

    Time frame: 30 days post-procedure

  8. Patient is converted from local to general anaesthetic/receives intubation during procedure

    Time frame: This happens during the procedure

  9. Myocardial infarction

    Time frame: This happens during the 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 at baseline, 30 days and 1 year

    Time frame: Baseline, and 30 days and 1 year post-procedure

Other outcomes

  1. Death or stroke

    Time frame: 1 year post-procedure

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03600935
Lead sponsor
BC Centre for Improved Cardiovascular Health
Collaborators
University of British Columbia
Responsible party
Sponsor
First posted
Jul 26, 2018
Start date
Oct 2018 (estimated)
Primary completion
Sep 2020 (estimated)
Completion
Sep 2021 (estimated)
Last update
Sep 25, 2018

Study contacts

David A Wood, MD
Contact
david.wood@vch.ca
6048755601
Shirley C Wong, PhD
Contact
safetavr@icvhealth.ubc.ca
6046822344 ext. 65676
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
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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