Evaluating a new sizing algorithm for transcatheter aortic valve replacement in patients with bicuspid aortic stenosis
A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
World Health Research Inc. · NCT06991517
This study is testing a new sizing method for heart valve replacement to see if it helps people with a specific heart condition feel better after their procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 290 (estimated) |
| Sex | All |
| Sponsor | World Health Research Inc. (industry) |
| Locations | 21 sites (New Lambton Heights, New South Wales and 20 other locations) |
| Trial ID | NCT06991517 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of the ABC Bicuspid Sizing Algorithm on clinical outcomes for patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. Approximately 290 patients will be enrolled, with their diagnostic images evaluated to determine the appropriate treatment and valve size. The study will track outcomes at baseline, procedure, hospital discharge, and follow-ups at 30 days and one year post-procedure. The study will also utilize advanced imaging techniques and artificial intelligence in select cases to enhance decision-making.
Who should consider this trial
Good fit: Ideal candidates are patients with bicuspid aortic valve disease and severe aortic stenosis who are eligible for TAVR with a Sapien 3 valve.
Not a fit: Patients who are not suitable for TAVR or are treated with a valve other than the Sapien 3 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the technical and device success rates of TAVR procedures for patients with bicuspid aortic stenosis.
How similar studies have performed: While the use of sizing algorithms in TAVR is a growing area of interest, this specific approach using the ABC Bicuspid Sizing Algorithm is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Lambton Heights, New South Wales and 20 other locations
- John Hunter Hospital — New Lambton Heights, New South Wales, Australia (NOT_YET_RECRUITING)
- North Shore Private Hospital — St Leonards, New South Wales, Australia (NOT_YET_RECRUITING)
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (RECRUITING)
- The Prince Charles Hospital — Chermside, Queensland, Australia (NOT_YET_RECRUITING)
- St Andrew's War Memorial Hospital — Spring Hill, Queensland, Australia (NOT_YET_RECRUITING)
- The Alfred — Melbourne, Victoria, Australia (RECRUITING)
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia (NOT_YET_RECRUITING)
- Foothills Medical Centre — Calgary, Alberta, Canada (NOT_YET_RECRUITING)
- NovaScotia Health Authority- Halifax Infimary — Halifax, NovaScotia, Canada (NOT_YET_RECRUITING)
- Hamilton General Hospital — Hamilton, Ontario, Canada (RECRUITING)
- Southlake Regional Health Centre — Newmarket, Ontario, Canada (NOT_YET_RECRUITING)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (RECRUITING)
- St. Michael's Hospital — Toronto, Ontario, Canada (RECRUITING)
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Quebec, Canada (RECRUITING)
- Fundación Cardioinfantil - LaCardio — Bogotá, Colombia (NOT_YET_RECRUITING)
- Hospital San Juan de Dios — San José, Provincia de San José, Costa Rica (NOT_YET_RECRUITING)
- Centro Médico Nacional Siglo XXI — Mexico City, Mexico (NOT_YET_RECRUITING)
- Instituto Nacional de Cardiología - Ignacio Chávez — Mexico City, Mexico (NOT_YET_RECRUITING)
- Wellington Regional Hospital — Newtown, Wellington Region, New Zealand (NOT_YET_RECRUITING)
- National Heart Centre Singapore — Singapore, Singapore (RECRUITING)
- Ramathibodi Hospital — Bangkok, Thailand (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Tej PM Sheth, MD, FRCPC — McMaster University, World Health Research Inc.
- Study coordinator: Sarah Tawadros, MD
- Email: sarah.tawadros@worldhealthresearch.ca
- Phone: 647-783-3521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Stenosis, Bicuspid Aortic Stenosis, Transcatheter Aortic Valve Replacement