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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06284837




Registration number
NCT06284837
Ethics application status
Date submitted
8/12/2023
Date registered
29/02/2024
Date last updated
4/03/2024

Titles & IDs
Public title
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Scientific title
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Secondary ID [1] 0 0
HREC/99382/Alfred-2023
Universal Trial Number (UTN)
Trial acronym
SAFER-TAVI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Valve Stenoses, Aortic 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Access site

Active comparator: Radial secondary access -

Active comparator: Femoral secondary access -


Other interventions: Access site
The SAFER-TAVI trial is randomized study comparing secondary access via a transradial versus transfemoral approach among patients undergoing transfemoral TAVI for aortic valve disease. Secondary access is gained along with primary access at the commencement of the TAVI procedure and is used for aortography before and after valve deployment and for assessment of the primary femoral access site after closure to confirm haemostasis. For patients assigned to radial access, the radial sheath will be removed using a radial band at the end of the procedure. For patients assigned to femoral access, the puncture site will be obtained under ultrasound guidance and fluoroscopic landmark identification. Unless contraindicated, the use of vascular closure devices will be recommended for all femoral cases. The choice of closure device is at the discretion of the operator. Catheters used in the access groups will be 5 or 6 French size at the discretion of the operator.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All bleeding and vascular complications
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
All bleeding
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
All vascular complications
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
All-cause death
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Stroke
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Myocardial infarction
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
Major adverse cardiovascular events
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Length of stay post-procedure
Timepoint [7] 0 0
30 days
Secondary outcome [8] 0 0
Overall procedure duration
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
Radiation dose
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
Conversion rate to alternative vascular access site
Timepoint [10] 0 0
30 days
Secondary outcome [11] 0 0
Tertiary site utilised to treat vascular complication
Timepoint [11] 0 0
30 days
Secondary outcome [12] 0 0
Failure to perform angiogram of primary access site at completion of TAVI
Timepoint [12] 0 0
1 day

Eligibility
Key inclusion criteria
* Age >18 years
* Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
* Suitable radial and secondary femoral access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary arterial access via surgical cut-down
* Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist
* Previously failed attempt to access bilateral radial arteries.
* Patient on hemodialysis

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
560
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment hospital [2] 0 0
Epworth Healthcare - Melbourne
Recruitment hospital [3] 0 0
Cabrini Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3121 - Melbourne
Recruitment postcode(s) [3] 0 0
3144 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Epworth Healthcare
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Cabrini Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site.
Trial website
https://clinicaltrials.gov/study/NCT06284837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antony Walton, MBBS
Address 0 0
The Alfred and Epworth Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Zhou, MBBS, BMedSc
Address 0 0
Country 0 0
Phone 0 0
+61390763263
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06284837