Actively Recruiting
A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
Led by World Health Research Inc. · Updated on 2025-11-28
290
Participants Needed
21
Research Sites
52 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
Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on patients with bicuspid aortic stenosis who undergo transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. This international, prospective cohort study aims to determine if the algorithm improves technical success immediately after the procedure and device success 30 days post-procedure. The study includes about 290 patients being considered for TAVR or surgical aortic valve replacement (SAVR). The ABC Bicuspid Sizing Algorithm helps physicians decide between TAVR and SAVR and guides valve sizing and deployment for TAVR patients. It incorporates diagnostic CT scans and may include gated computed tomography or artificial intelligence-based simulations in some cases to assess borderline feasibility. Approximately 230 patients will undergo TAVR based on the algorithm's recommendations, while others will have SAVR. Treatment decisions are made using the algorithm alongside clinical judgment. Participants will have data collected at several points: baseline, during the procedure, at hospital discharge, and at 30 days and one year after the procedure if treated with TAVR. SAVR patients will have data collected at baseline and during the procedure only. Outcomes measured include technical and device success, conduction disturbances, vascular complications, stroke, valve function, and survival. The study lasts through the one-year follow-up after the procedure, involving multiple clinical assessments and imaging reviews.
CONDITIONS
Brief 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 of diagnostic quality including multiphase reconstructions of the aortic root
- Would be treated with a Sapien 3 valve if anatomically suitable for TAVR
- Have a suitable access route for TAVR with a Sapien 3 valve
You will not qualify if you...
- Treated with TAVR using a device other than a Sapien 3 valve
- Unable to be treated with TAVR due to intercurrent illness, clinical instability, or death on waitlist after acceptance for TAVR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline period
Participants undergo evaluation using the ABC Bicuspid Sizing Algorithm, including CT scans and possibly gated CT evaluation or AI-based simulation models to help guide treatment decisions between TAVR and surgical aortic valve replacement.
1 visit (in-person)
Duration - Procedure day
Participants receive treatment with either transcatheter aortic valve replacement (TAVR) using a Sapien 3 valve or surgical aortic valve replacement (SAVR) as determined by the treating physicians based on the algorithm and clinical factors.
1 visit (procedure day)
Duration - Until hospital discharge
Participants treated with TAVR are monitored during their hospital stay after the procedure.
Approximately 1 to 2 visits during hospital stay
Duration - 1 year
Participants treated with TAVR have follow-up visits for safety and outcome assessments at 30 days and 1 year after the procedure.
2 visits (at 30 days and 1 year post-procedure)
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
F
Frank Naus
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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