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

Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: Vancouver Clinical Pathway

• Study Type: Interventional
• Enrollment (Anticipated): 315
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Vancouver Clinical Pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	30 days post-procedure
Stroke	30 days post-procedure
New permanent pacemaker	30 days post-procedure
Repeat procedure for valve-related dysfunction	30 days post-procedure
Stage 3 acute kidney injury (need for dialysis)	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
>mild paravalvular regurgiation	Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure
Patient is converted from local to general anaesthetic/receives intubation during procedure	This happens during the procedure
Myocardial infarction	This happens during the procedure
Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year	Baseline, and 30 days and 1 year post-procedure

Other Outcome Measures

Outcome Measure	Time Frame
Death or stroke	1 year post-procedure

Collaborators and Investigators

• Sponsor: BC Centre for Improved Cardiovascular Health
• Collaborators: University of British Columbia

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: TBD1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No