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

NCT03600935 | Unknown DMC

• 1 other identifier: TBD1
• Study Type: interventional
• Target: 315
• Locations: 0 countries
• Sites: N/A

Brief 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.

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 Clinical Pathway, who are discharged the next day

  Discharge 1 day after procedure

Secondary Outcomes (12)

• All-cause mortality

  30 days post-procedure

• Stroke

  30 days post-procedure

• Major vascular complications

  30 days post-procedure

• Major/Life-threatening bleed

  30 days post-procedure

• Any hospital readmission

  30 days post-procedure

Other Outcomes (1)

• Death or stroke

  1 year post-procedure

Study Arms (1)

Vancouver Clinical Pathway

EXPERIMENTAL

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

Vancouver Clinical Pathway OTHER

Vancouver Clinical Pathway

Vancouver Clinical Pathway

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding 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
• 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
• Surgical prosthesis \<23 mm (labelled size) for valve-in-valve procedure
• In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
• Language barriers (inability to understand peri-procedural and discharge instructions)
• Insufficient social support post procedure to allow next day discharge
• Airway unfavourable for emergent intubation
• Inability to lay supine without conscious sedation or general anaesthetic

Sponsors & Collaborators

• BC Centre for Improved Cardiovascular Health: lead
• University of British Columbia: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• David A Wood, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• John A Webb, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Wood, MD

CONTACT

6048755601; david.wood@vch.ca

Shirley C Wong, PhD

CONTACT

6046822344; safetavr@icvhealth.ubc.ca

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: July 4, 2018
• First Posted: July 26, 2018
• Study Start: October 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: September 25, 2018

Record last verified: 2018-07