Recruiting

ABC Bicuspid Sizing

Sponsor:

World Health Research Inc.

Code:

NCT06991517

Conditions

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

The ABC Bicuspid Sizing Algorithm

Study Details

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. 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.

Conditions

Aortic Stenosis

Study ID

NCT06991517

Start date

May 13, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

290 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • Proportion of cases achieving technical success [ Time Frame: At exit from procedure room after procedure completion ]

Central Contacts and Locations

Central contacts

Sarah Tawadros, MD

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

Frank Naus

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

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

NovaScotia Health Authority- Halifax Infimary

Recruiting

Halifax, NovaScotia, Canada, B3H 3A7

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

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

Recruiting

Québec, Quebec, Canada, G1V 4G5

More Information

Sponsor

World Health Research Inc.

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Bicuspid Aortic Stenosis
  • Transcatheter Aortic Valve Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by World Health Research Inc. on 2026-07-21.