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CT scans could help pick the perfect heart valve size

NCT ID NCT05799573

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether CT scans can help doctors choose the right size for the Perceval sutureless heart valve. The valve is used to replace a leaky aortic valve. Researchers studied 50 patients to see if CT-based sizing leads to good early results after surgery, like proper valve function and fewer complications.

What this could mean

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

Active substance
Perceval sutureless aortic valve
What this could lead to
If successful, this could make pre-surgery valve sizing more accurate, potentially reducing complications.
What could go wrong
This is a small, completed study with only 50 participants, so results may not apply to everyone. It focuses on sizing, not on long-term outcomes.

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

50 people

The number who actually took part.

Started

Dec 2022

Finished

Apr 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

Patients with indication for aortic valve replacement with a Perceval valve

Ages

18 years and older

Sex

Anyone

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: 1. Male and female subjects \> 18 years; 2. Subjects willing to sign and date an informed consent for treatment of personal data; 3. Subjects willing and able to comply with the follow up schedule of the protocol; 4. Subjects with indication for aortic valve replacement on a tricuspid aortic valve; 5. Subjects with possibly associated need for coronary revascularization. 6. Subjects with Ejection Fraction ≥ 40% Exclusion Criteria: 1. Male and female subjects ≤ 18 years; 2. Subjects with bicuspid aortic valve 3. Subjects with associated mitral valvulopathy or ascending aorta aneurysm 4. Subjects with pure aortic insufficiency 5. Subjects with Ejection Fraction \< 40% 6. Subjects with acute myocardial infarction \< 30 gg 7. Subjects with serum creatinine \> 2 mg/Dl

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency

As listed by the trial registrant

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

Aortic valve regurgitation

Contacts and locations

Locations

  • Maria Cecilia Hospital

    Cotignola, Ravenna, 48033, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.