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

Recruiting now

Conditions studied: Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT06991517

Run by

World Health Research Inc.

People needed

290

Starts

2025-05-13

Expected to finish

2031-12-01

Last updated by the study team

2026-07-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• North Shore Private Hospital — St Leonards, New South Wales, Australia (enrolling)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia (enrolling)
• The Prince Charles Hospital — Chermside, Queensland, Australia (enrolling)
• St Andrew's War Memorial Hospital — Spring Hill, Queensland, Australia (enrolling)
• The Alfred — Melbourne, Victoria, Australia (enrolling)
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia (enrolling)
• Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)
• NovaScotia Health Authority- Halifax Infimary — Halifax, NovaScotia, Canada (enrolling)
• Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
• Wellington Regional Hospital — Newtown, Wellington Region, New Zealand (enrolling)
• Christchurch Hospital — Christchurch, New Zealand (enrolling)
• National Heart Centre Singapore — Singapore, Singapore (enrolling)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Quebec, Canada (enrolling)
• Fundación Cardioinfantil - LaCardio — Bogotá, Colombia (enrolling)
• Centro Médico Nacional Siglo XXI — Mexico City, Mexico (enrolling)
• Southlake Regional Health Centre — Newmarket, Ontario, Canada
• Hospital San Juan de Dios — San José, Provincia de San José, Costa Rica
• Ramathibodi Hospital — Bangkok, Thailand

Full record on ClinicalTrials.gov

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