A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm (NCT06991517)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (5 items).
Location: North Shore Private Hospital — St Leonards, New South Wales
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (20 Sites)
- North Shore Private Hospital — St Leonards, New South Wales
- Royal North Shore Hospital — St Leonards, New South Wales
- The Prince Charles Hospital — Chermside, Queensland
- St Andrew's War Memorial Hospital — Spring Hill, Queensland
- The Alfred — Melbourne, Victoria
- Fiona Stanley Hospital — Murdoch, Western Australia
- Foothills Medical Centre — Calgary, Alberta
- NovaScotia Health Authority- Halifax Infimary — Halifax, NovaScotia
- Hamilton General Hospital — Hamilton, Ontario
- Southlake Regional Health Centre — Newmarket, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario
- St. Michael's Hospital — Toronto, Ontario
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Quebec
- Fundación Cardioinfantil - LaCardio — Bogotá,
- Hospital San Juan de Dios — San José, Provincia de San José
- Centro Médico Nacional Siglo XXI — Mexico City,
- Wellington Regional Hospital — Newtown, Wellington Region
- Christchurch Hospital — Christchurch,
- National Heart Centre Singapore — Singapore,
- Ramathibodi Hospital — Bangkok,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.