🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

Recruitingn/aAges any - anyAllWorld Health Research Inc.
NCT06991517 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • The ABC Bicuspid Sizing Algorithm
📍

Where

20 sites
North Shore Private Hospital
St Leonards, Australia
Royal North Shore Hospital
St Leonards, Australia
The Prince Charles Hospital
Chermside, Australia
St Andrew's War Memorial Hospital
Spring Hill, Australia
The Alfred
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Foothills Medical Centre
Calgary, Canada
NovaScotia Health Authority- Halifax Infimary
Halifax, Canada

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy