Evaluating a new sizing algorithm for transcatheter aortic valve replacement in patients with bicuspid aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• North Shore Private Hospital
  St Leonards, New South Wales, Australia Recruiting
• Royal North Shore Hospital
  St Leonards, New South Wales, Australia Recruiting
• The Prince Charles Hospital
  Chermside, Queensland, Australia Recruiting
• St Andrew's War Memorial Hospital
  Spring Hill, Queensland, Australia Recruiting
• The Alfred
  Melbourne, Victoria, Australia Recruiting
• Fiona Stanley Hospital
  Murdoch, Western Australia, Australia 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.