The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vancouver 3M Clinical Pathway

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.

Group Type EXPERIMENTAL

Vancouver 3M Clinical Pathway

Intervention Type OTHER

Interventions

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Vancouver 3M Clinical Pathway

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No