Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
Sponsor: World Health Research Inc.
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 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.
Official title: A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
290
Start Date
2025-05-13
Completion Date
2027-12
Last Updated
2025-11-28
Healthy Volunteers
No
Conditions
Interventions
The ABC Bicuspid Sizing Algorithm
The ABC Bicuspid Sizing Algorithm is a valve sizing algorithm. It guides operators' evaluations of CT scans, helping inform (1) treatment allocation between TAVR and surgical aortic valve replacement, and (2) valve choice for patients undergoing TAVR. In select cases, the algorithm will suggest gated CT evaluation or artificial intelligence-based simulation models be used to further evaluate the risk of the planned valve size and deployment volume. The operators will consider the findings of the ABC Bicuspid Sizing Algorithm as well as other clinical factors when making their final treatment decisions.
Locations (21)
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
North Shore Private Hospital
St Leonards, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
St Andrew's War Memorial Hospital
Spring Hill, Queensland, Australia
The Alfred
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Foothills Medical Centre
Calgary, Alberta, Canada
NovaScotia Health Authority- Halifax Infimary
Halifax, NovaScotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canada
Fundación Cardioinfantil - LaCardio
Bogotá, Colombia
Hospital San Juan de Dios
San José, Provincia de San José, Costa Rica
Centro Médico Nacional Siglo XXI
Mexico City, Mexico
Instituto Nacional de Cardiología - Ignacio Chávez
Mexico City, Mexico
Wellington Regional Hospital
Newtown, Wellington Region, New Zealand
National Heart Centre Singapore
Singapore, Singapore
Ramathibodi Hospital
Bangkok, Thailand