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AI may spot dangerous aortic growth before it happens

NCT ID NCT07782918

Knowledge-focused Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study is testing whether an artificial intelligence model can predict how the aorta might dilate (widen) in people with bicuspid aortic valve—a common heart valve condition that raises the risk of aortic aneurysm. Researchers will analyze CT scans from 1,000 patients who had a minimally invasive valve replacement (TAVR) to look for early signs of deformation and blood flow changes. The goal is to build a tool that gives doctors a clearer, earlier warning of dangerous aortic growth, potentially enabling earlier intervention and better outcomes.

What this could mean

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

Active substance
An AI-based risk prediction model using imaging data (vascular deformation mapping and computational fluid dynamics) to forecast aortic dilation after TAVR.
What this could lead to
If successful, this could enable earlier detection of dangerous aortic dilation in BAV patients, potentially guiding timely interventions and improving outcomes.
What could go wrong
The model is still in development and validation; it may not generalize to all patients or outperform current manual measurements. Its accuracy depends on imaging quality and retrospective data.

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

1,000 people

The number who actually took part.

Started

Jan 2020

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Approximately 1,000 BAV patients who underwent TAVR will be retrospectively enrolled from two Chinese tertiary hospitals. Eligible patients are aged 18-85 years with serial CTA (pre-op, post-op, follow-up) covering the aorta from supra-aortic branches to iliac arteries. Exclusions: connective tissue disorders, prior aortic surgery, dissection, isolated aneurysm, poor image quality, or registration failure. No additional interventions are administered. All patients are analyzed as a single observational cohort.

Ages

18 to 85 years

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: Patients are eligible for inclusion if they are male or non-pregnant female aged 18 to 85 years, diagnosed with Bicuspid Aortic Valve (BAV) by CTA, and have successfully undergone Transcatheter Aortic Valve Replacement (TAVR) with available pre-operative, post-operative (1-3 months), and follow-up (6-12 months) CTA imaging. The CTA scan range must cover cranially at least the origin of the brachiocephalic trunk, left common carotid artery, and left subclavian artery, and caudally at least the origin of the internal and external iliac arteries. Exclusion Criteria: Patients are excluded if they have traumatic or iatrogenic aortic dissection, isolated aortic aneurysm without BAV, connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, or prior cardiac or aortic surgery including surgical aortic valve replacement or aortic repair. Additional exclusions include insufficient number of CTA scans or inadequate scan range, poor CTA image quality due to motion artifacts or inadequate contrast enhancement precluding accurate segmentation, or image registration failure precluding completion of VDM analysis.

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Conditions

The condition(s) this trial relates to.

aortic aneurysm aortic valve disease 1 aortic valve disease 2 Bicuspid Aortic Valve Disease

As listed by the trial registrant

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

Aortic aneurysm Bicuspid aortic valve (BAV) TAVR

Contacts and locations

Locations

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

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