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New CT algorithm aims to perfect heart valve sizing for tricky bicuspid patients

NCT ID NCT06991517

Disease control Sponsor: World Health Research Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study is testing a new CT-based sizing algorithm (the ABC Bicuspid Sizing Algorithm) to help doctors choose the right valve size and procedure for people with bicuspid aortic stenosis who need a transcatheter aortic valve replacement (TAVR). About 290 participants will have their CT scans analyzed using the algorithm to guide treatment. Researchers will check if this approach leads to better technical success right after the procedure and better valve function at 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABC Bicuspid Sizing Algorithm (a CT scan evaluation tool)
What this could lead to
If successful, this algorithm could help doctors choose the right valve size and procedure for people with bicuspid aortic stenosis, potentially reducing complications and improving TAVR outcomes.
What could go wrong
This is an early-stage observational study, not a randomized trial. The algorithm may not improve outcomes for all patients, and results may not apply to everyone with this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients referred to the TAVR program at select hospitals

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centro Médico Nacional Siglo XXI

    RECRUITING

    Mexico City, 06720, Mexico

  • Christchurch Hospital

    RECRUITING

    Christchurch, 4710, New Zealand

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Foothills Medical Centre

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • Fundación Cardioinfantil - LaCardio

    RECRUITING

    Bogotá, 111011, Colombia

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Hospital San Juan de Dios

    NOT_YET_RECRUITING

    San José, Provincia de San José, 10104, Costa Rica

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • National Heart Centre Singapore

    RECRUITING

    Singapore, 169609, Singapore

  • North Shore Private Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • NovaScotia Health Authority- Halifax Infimary

    RECRUITING

    Halifax, NovaScotia, B3H 3A7, Canada

  • Ramathibodi Hospital

    NOT_YET_RECRUITING

    Bangkok, 10400, Thailand

  • Royal North Shore Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Southlake Regional Health Centre

    NOT_YET_RECRUITING

    Newmarket, Ontario, L3Y 2P9, Canada

  • St Andrew's War Memorial Hospital

    RECRUITING

    Spring Hill, Queensland, 4000, Australia

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • The Alfred

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Prince Charles Hospital

    RECRUITING

    Chermside, Queensland, 4032, Australia

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

  • Wellington Regional Hospital

    RECRUITING

    Newtown, Wellington Region, 6021, New Zealand

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