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

NCT06991517 | Recruiting

• 1 other identifier: 5168-CTIA-Feb/2025-117711
• Study Type: observational
• Target: 290
• Locations: 7 countries
• Sites: 20

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 replacement (TAVR) using the Sapien 3 valve. The main questions the study aims to answer are:

1. 1.Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room?
2. 2.Does the ABC Bicuspid Sizing Algorithm increase the device success at 30 days after the procedure?

Conditions

Aortic Stenosis

Keywords

Bicuspid Aortic Stenosis; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Proportion of cases achieving technical success

  Freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or cardiac structural complication

  At exit from procedure room after procedure completion

Secondary Outcomes (11)

• Proportion of cases achieving device success

  At 30 days after the procedure

• Proportion of cases in which the use of gated computed tomography evaluation or artificial intelligence-based simulation models altered the treatment plan or operator confidence in the treatment plan compared to the ABC Bicuspid Sizing Algorithm alone

  At baseline

• New conduction disturbance and permanent pacemaker implantation

  At 30 days and 1 year after the procedure

• Stroke or transient ischemic attack

  At 30 days and 1 year after the procedure

• Major vascular complication

  At 30 days after the procedure

Interventions

The ABC Bicuspid Sizing Algorithm OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the TAVR program at select hospitals

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• World Health Research Inc.: lead
• Edwards Lifesciences: collaborator

Study Sites (21)

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

NOT YET RECRUITING

North Shore Private Hospital

St Leonards, New South Wales, 2065, Australia

NOT YET RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

NOT YET RECRUITING

St Andrew's War Memorial Hospital

Spring Hill, Queensland, 4000, Australia

NOT YET RECRUITING

The Alfred

Melbourne, Victoria, 3004, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

NOT YET RECRUITING

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

NOT YET RECRUITING

NovaScotia Health Authority- Halifax Infimary

Halifax, NovaScotia, B3H 3A7, Canada

NOT YET RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

NOT YET RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

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

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Fundación Cardioinfantil - LaCardio

Bogotá, 111011, Colombia

NOT YET RECRUITING

Hospital San Juan de Dios

San José, Provincia de San José, 10104, Costa Rica

NOT YET RECRUITING

Centro Médico Nacional Siglo XXI

Mexico City, 06720, Mexico

NOT YET RECRUITING

Instituto Nacional de Cardiología - Ignacio Chávez

Mexico City, 14080, Mexico

NOT YET RECRUITING

Wellington Regional Hospital

Newtown, Wellington Region, 6021, New Zealand

NOT YET RECRUITING

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Ramathibodi Hospital

Bangkok, 10400, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Tej PM Sheth, MD, FRCPC

  McMaster University, World Health Research Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Tawadros, MD

CONTACT

647-783-3521; sarah.tawadros@worldhealthresearch.ca

Frank Naus

CONTACT

416-706-2579; frank.naus@worldhealthresearch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 28, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

TH (1); CO (1); AU (7); CA (7); NZ (1); ME (2); SG (1)