A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm

RecruitingOBSERVATIONAL
Enrollment

290

Participants

Timeline

Start Date

May 13, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Aortic Stenosis
Interventions
OTHER

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.

Trial Locations (20)

2065

NOT_YET_RECRUITING

North Shore Private Hospital, St Leonards

NOT_YET_RECRUITING

Royal North Shore Hospital, St Leonards

2305

NOT_YET_RECRUITING

John Hunter Hospital, New Lambton Heights

3004

NOT_YET_RECRUITING

The Alfred, Melbourne

4000

NOT_YET_RECRUITING

St Andrew's War Memorial Hospital, Spring Hill

4032

NOT_YET_RECRUITING

The Prince Charles Hospital, Chermside

6021

NOT_YET_RECRUITING

Wellington Regional Hospital, Newtown

6150

NOT_YET_RECRUITING

Fiona Stanley Hospital, Murdoch

10104

NOT_YET_RECRUITING

Hospital San Juan de Dios, San José

10400

NOT_YET_RECRUITING

Ramathibodi Hospital, Bangkok

14080

NOT_YET_RECRUITING

Instituto Nacional de Cardiología - Ignacio Chávez, Mexico City

111011

NOT_YET_RECRUITING

Fundación Cardioinfantil - LaCardio, Bogotá

169609

NOT_YET_RECRUITING

National Heart Centre Singapore, Singapore

T2N 2T9

NOT_YET_RECRUITING

Foothills Medical Centre, Calgary

L8L 2X2

RECRUITING

Hamilton General Hospital, Hamilton

L3Y 2P9

NOT_YET_RECRUITING

Southlake Regional Health Centre, Newmarket

K1Y 4W7

NOT_YET_RECRUITING

University of Ottawa Heart Institute, Ottawa

M5B 1W8

NOT_YET_RECRUITING

St. Michael's Hospital, Toronto

G1V 4G5

NOT_YET_RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval, Québec

06720

NOT_YET_RECRUITING

Centro Médico Nacional Siglo XXI, Mexico City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Edwards Lifesciences

INDUSTRY

lead

World Health Research Inc.

INDUSTRY