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A new way to size heart valves: could the 'circle method' reduce TAVI complications?

NCT ID NCT05844969

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study looks at whether the 'circle method' — a way to measure the aortic valve — can help doctors choose the right size replacement valve for people with bicuspid aortic valves who are getting a TAVI procedure. Researchers will review past cases to see if patients whose valve size matched the circle method had fewer complications. The goal is to develop better sizing guidelines for this challenging condition.

What this could mean

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

What this could lead to
If validated, the circle method could help doctors select the optimal valve size for TAVI in patients with bicuspid aortic valves, potentially reducing complications.
What could go wrong
This is a retrospective analysis of existing data, not a prospective trial. The findings may not apply to all patients or valve types.

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

140 people

The number who actually took part.

Started

Jun 2025

Finished

Jun 2026

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Adult patients with bicuspid valve disease who underwent aortic valve replacement.

Ages

18 years and older

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 with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra) * Computed Tomography data available Exclusion Criteria: \- none

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Guy's and St Thomas NHS Foundation Trust

    London, SE17EH, United Kingdom

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, CB20AY, United Kingdom

  • The Essex Cardiothoracic Centre

    Basildon, England, SS16 5NL, United Kingdom

  • University Hospitals Sussex NHS Foundation Trust

    Worthing, BN112DH, United Kingdom

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