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CT or surgery: which measures heart valves best?

NCT ID NCT07125469

Knowledge-focused Sponsor: Maria Cecilia Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 82 people with severe aortic stenosis who need open-heart surgery to replace their aortic valve. Before surgery, each person gets a CT scan to measure the valve. During surgery, doctors also measure the valve with special tools. The goal is to see which method gives a more accurate size for the replacement valve, helping surgeons pick the best fit.

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 successful, this could help surgeons choose the right valve size more accurately, potentially reducing complications in aortic valve replacement.
What could go wrong
This is a small, observational study (82 people) that does not test a new treatment, so it may not change practice directly. Differences in measurement methods could still lead to uncertainty.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 82 people

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

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

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: Patient age 18 years or older All patients with isolated severe Aortic Stenosis (AS) considered eligible for Surgical Aortic Valve Replacement (SAVR) according to the current 2023 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines for management of Valvular Heart Disease (reference 8) will be enrolled. Patient is willing to comply with study procedures and is available to return to the center for follow-up visits. Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate. Exclusion Criteria: Bicuspid aortic valve anatomy Moderate to severe aortic valve regurgitation Multivalvular disease Redo Surgical Aortic Valve Replacement Ascending aorta aneurysm Aortic root enlargement Chronic Kidney Disease with estimated Glomerular Filtration Rate less than 30 milliliters per minute Body Mass Index greater than 30 kilograms per square meter Inadequate Multidetector Computed Tomography images

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis heart valve disorder

As listed by the trial registrant

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

Valvular heart disease

How to take part

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

  1. The places running it

    1 site. 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

  • Maria Cecilia Hospital

    RECRUITING

    Cotignola, Ravenna, 48033, Italy

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