The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement (3MTAVR)

BC Centre for Improved Cardiovascular Health

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Other: Vancouver 3M Clinical Pathway

Study type: Interventional

Funder types: Other

Identifier

NCT02287662

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 balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.

Enrollment: 411 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a balloon expandable 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. Iliofemoral diameter < 6 mm for SAPIEN XT or <5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head)
6. Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons.
7. Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions
8. 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
9. Insufficient social support to facilitate next day discharge
10. Airway unfavourable for emergent intubation
11. Inability to lay supine without conscious sedation or general anesthetic
12. Not receiving a balloon expandable transcatheter heart valve

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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411 participants in 1 patient group

Vancouver 3M Clinical Pathway

Experimental group

Description:

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.

Treatment:

Other: Vancouver 3M Clinical Pathway