Actively Recruiting
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
Led by World Health Research Inc. · Updated on 2025-11-28
290
Participants Needed
21
Research Sites
133 weeks
Total Duration
On this page
Sponsors
W
World Health Research Inc.
Lead Sponsor
E
Edwards Lifesciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 replacement (TAVR) using the Sapien 3 valve. The main questions the study aims to answer are: 1. Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room? 2. Does the ABC Bicuspid Sizing Algorithm increase the device success at 30 days after the procedure? Participants already being evaluated for a TAVR as part of their regular medical care for bicuspid aortic stenosis will have their diagnostic images assessed using the ABC Bicuspid Sizing Algorithm to help determine their procedure type and valve size. They will have visits 30 days and one year after their procedure.
CONDITIONS
Official Title
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
Not Yet Recruiting
2
North Shore Private Hospital
St Leonards, New South Wales, Australia, 2065
Not Yet Recruiting
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
4
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Not Yet Recruiting
5
St Andrew's War Memorial Hospital
Spring Hill, Queensland, Australia, 4000
Not Yet Recruiting
6
The Alfred
Melbourne, Victoria, Australia, 3004
Actively Recruiting
7
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
8
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Not Yet Recruiting
9
NovaScotia Health Authority- Halifax Infimary
Halifax, NovaScotia, Canada, B3H 3A7
Not Yet Recruiting
10
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
11
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Not Yet Recruiting
12
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
13
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
14
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
15
Fundación Cardioinfantil - LaCardio
Bogotá, Colombia, 111011
Not Yet Recruiting
16
Hospital San Juan de Dios
San José, Provincia de San José, Costa Rica, 10104
Not Yet Recruiting
17
Centro Médico Nacional Siglo XXI
Mexico City, Mexico, 06720
Not Yet Recruiting
18
Instituto Nacional de Cardiología - Ignacio Chávez
Mexico City, Mexico, 14080
Not Yet Recruiting
19
Wellington Regional Hospital
Newtown, Wellington Region, New Zealand, 6021
Not Yet Recruiting
20
National Heart Centre Singapore
Singapore, Singapore, 169609
Actively Recruiting
21
Ramathibodi Hospital
Bangkok, Thailand, 10400
Not Yet Recruiting
Research Team
S
Sarah Tawadros, MD
CONTACT
F
Frank Naus
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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