Status:
RECRUITING
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
Lead Sponsor:
World Health Research Inc.
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Aortic Stenosis
Eligibility:
All Genders
Brief Summary
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve repla...
Detailed Description
This is a multi-centre, international, prospective cohort study. Approximately 290 patients who are clinically eligible for transcatheter aortic valve replacement (TAVR) will be enrolled. Using inform...
Eligibility Criteria
Inclusion
- Have bicuspid aortic valve disease
- Have severe aortic stenosis or mixed aortic stenosis and regurgitation requiring treatment
- Have no other condition requiring surgical intervention
- Have had a TAVR CT scan (retrospectively gated contrast enhanced acquisition) that is of diagnostic quality and includes multiphase reconstructions of the aortic root at the minimum available slice thickness (with at least three systolic and one diastolic phases)
- Would be treated with a Sapien 3 valve if found to be anatomically suitable for TAVR
- Have a suitable access route for TAVR with a Sapien 3 valve
Exclusion
- Are treated with TAVR using a device other than a Sapien 3 valve
- Are unable to be treated with TAVR due to intercurrent illness, clinical instability, or death on waitlist after being accepted for TAVR
Key Trial Info
Start Date :
May 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT06991517
Start Date
May 13 2025
End Date
December 1 2027
Last Update
November 28 2025
Active Locations (21)
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1
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
2
North Shore Private Hospital
St Leonards, New South Wales, Australia, 2065
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
4
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032