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

Aortic Valve Stenosis Clinical Trial

— SAFETAVR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03600935
• Other study ID #: TBD1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: September 2021

Study information

• Verified date: July 2018
• Source: BC Centre for Improved Cardiovascular Health
• Contact: David A Wood, MD
• Phone: 6048755601
• Email: david.wood[@]vch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 315
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Other:
• Vancouver Clinical Pathway
Vancouver Clinical Pathway

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
BC Centre for Improved Cardiovascular Health	University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death or stroke		1 year post-procedure
Primary	The composite of all-cause mortality or stroke		30 days post-procedure
Primary	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	All-cause mortality		30 days post-procedure
Secondary	Stroke		30 days post-procedure
Secondary	Major vascular complications		30 days post-procedure
Secondary	Major/Life-threatening bleed		30 days post-procedure
Secondary	Any hospital readmission		30 days post-procedure
Secondary	>mild paravalvular regurgiation		Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure
Secondary	New permanent pacemaker		30 days post-procedure
Secondary	Patient is converted from local to general anaesthetic/receives intubation during procedure		This happens during the procedure
Secondary	Myocardial infarction		This happens during the procedure
Secondary	Repeat procedure for valve-related dysfunction		30 days post-procedure
Secondary	Stage 3 acute kidney injury (need for dialysis)		30 days post-procedure
Secondary	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