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

BC Centre for Improved Cardiovascular Health

Status: Unknown

Conditions: Aortic Valve Stenosis

Treatments: Other: Vancouver Clinical Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT03600935

TBD1

Details and patient eligibility

About

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.

Enrollment: 315 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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315 participants in 1 patient group

Vancouver Clinical Pathway

Experimental group

Description:

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.

Treatment:

Other: Vancouver Clinical Pathway