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

NCT06991517 · tracked via the Priya Life Science Australia tracker

Sponsor

World Health Research Inc

Phase

Observational

Started

2025-05-13

Last updated

2026-07-21

Condition(s) studied

Aortic Stenosis

Investigational drug(s) / intervention(s)

The ABC Bicuspid Sizing Algorithm

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.

Study 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 annually till 5 years after their procedure.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * TAVR considered high risk and not feasible due to risk of coronary occlusion, risk of sino tubular junction (STJ) injury and severe LVOT calcification * Annular area less than 275 mm² or more than 750 mm²

Primary outcome measure(s)

Proportion of cases achieving technical success — At exit from procedure room after procedure completion
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

Trial sites (20)

Facility	City	Region	Status
North Shore Private Hospital	St Leonards	New South Wales	Recruiting
Royal North Shore Hospital	St Leonards	New South Wales	Recruiting
The Prince Charles Hospital	Chermside	Queensland	Recruiting
St Andrew's War Memorial Hospital	Spring Hill	Queensland	Recruiting
The Alfred	Melbourne	Victoria	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
Foothills Medical Centre	Calgary	Alberta	Recruiting
NovaScotia Health Authority- Halifax Infimary	Halifax	NovaScotia	Recruiting
Hamilton General Hospital	Hamilton	Ontario	Recruiting
Southlake Regional Health Centre	Newmarket	Ontario	Not Yet Recruiting
University of Ottawa Heart Institute	Ottawa	Ontario	Recruiting
St. Michael's Hospital	Toronto	Ontario	Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Québec	Quebec	Recruiting
Fundación Cardioinfantil - LaCardio	Bogotá	Colombia	Recruiting
Hospital San Juan de Dios	San José	Provincia de San José	Not Yet Recruiting
Centro Médico Nacional Siglo XXI	Mexico City	Mexico	Recruiting
Wellington Regional Hospital	Newtown	Wellington Region	Recruiting
Christchurch Hospital	Christchurch	New Zealand	Recruiting
National Heart Centre Singapore	Singapore	Singapore	Recruiting
Ramathibodi Hospital	Bangkok	Thailand	Not Yet Recruiting

Other trials for the same condition

Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion Starting soon

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study Recruiting

Post-Market Clinical Follow Up Study With Navitor Valve Recruiting

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06991517 on ClinicalTrials.gov ↗ ← All trials in Australia