Clinical trial NCT03600935: Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
Official title: Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Replacement
Lead sponsor: BC Centre for Improved Cardiovascular Health
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2018-07-26
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The composite of all-cause mortality or stroke
timeFrame: 30 days post-procedure
measure: The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day
timeFrame: Discharge 1 day after procedure
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days post-procedure
measure: Stroke
timeFrame: 30 days post-procedure
measure: Major vascular complications
timeFrame: 30 days post-procedure
measure: Major/Life-threatening bleed
timeFrame: 30 days post-procedure
measure: Any hospital readmission
timeFrame: 30 days post-procedure
measure: >mild paravalvular regurgiation
timeFrame: Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure
measure: New permanent pacemaker
timeFrame: 30 days post-procedure
measure: Patient is converted from local to general anaesthetic/receives intubation during procedure
timeFrame: This happens during the procedure
measure: Myocardial infarction
timeFrame: This happens during the procedure
measure: Repeat procedure for valve-related dysfunction
timeFrame: 30 days post-procedure
measure: Stage 3 acute kidney injury (need for dialysis)
timeFrame: 30 days post-procedure
measure: Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year
timeFrame: Baseline, and 30 days and 1 year post-procedure
Other outcomes:
measure: Death or stroke
timeFrame: 1 year post-procedure
Locations:
Study officials:
affiliation: University of British Columbia
name: David A Wood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: John A Webb, MD
role: PRINCIPAL_INVESTIGATOR
References: