NCT06991517 A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
| NCT ID | NCT06991517 |
| Status | Recruiting |
| Phase | — |
| Sponsor | World Health Research Inc. |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 290 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 290 participants in total. It began in 2025-05-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 * 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
Contact & Investigator
Tej PM Sheth, MD, FRCPC
PRINCIPAL INVESTIGATOR
McMaster University, World Health Research Inc.
Frequently Asked Questions
Who can join the NCT06991517 clinical trial?
This trial is open to participants of all sexes, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06991517 currently recruiting?
Yes, NCT06991517 is actively recruiting participants. Contact the research team at sarah.tawadros@worldhealthresearch.ca for enrollment information.
Where is the NCT06991517 trial being conducted?
This trial is being conducted at St Leonards, Australia, St Leonards, Australia, Chermside, Australia, Spring Hill, Australia and 11 additional locations.
Who is sponsoring the NCT06991517 clinical trial?
NCT06991517 is sponsored by World Health Research Inc.. The principal investigator is Tej PM Sheth, MD, FRCPC at McMaster University, World Health Research Inc.. The trial plans to enroll 290 participants.