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Could a donor heart valve beat Man-Made ones for treating severe valve infections?

NCT ID NCT05253469

Disease control Sponsor: Centre Cardiologique du Nord 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study compares two approaches for replacing an infected aortic valve: using a cryopreserved aortic homograft (a preserved human donor valve) versus conventional mechanical or tissue prosthetic valves. The goal is to see which method leads to fewer complications, such as death, recurrent valve leakage, or the need for another surgery. The analysis includes 760 patients with infective endocarditis involving the aortic valve, some of whom also have heart failure. By matching patients with similar characteristics, the researchers aim to determine if the donor valve offers any advantage in this challenging condition.

What this could mean

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

Active substance
Cryopreserved aortic homograft (a preserved human donor aortic valve) compared with conventional mechanical or stent xenograft prosthetic valves
What this could lead to
If this comparison shows that using a preserved human donor valve reduces complications and repeat surgeries, it could establish a better standard for treating complex heart valve infections.
What could go wrong
This is an observational analysis, not a randomized trial, so results may be influenced by patient differences. Homografts may also be harder to obtain and may not always outperform prosthetic valves.

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 760 people

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

Started

Jan 2005

Expected to finish

Dec 2028

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.

Who is studied

Adults with aortic valve endocarditis with or without infection extending to other heart structures who were symptomatic of congestive heart failure and unresponsive to medical therapy and who were eligible for surgical aortic valve replacement. The severity of AMR was assessed by transthoracic echocardiography, performed using the European Society of Echocardiography criteria.

Ages

18 to 90 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: * Duke Criteria * Uncontrolled Infection Local abscess Large vegetation False aneurysm, Fistula, Dehiscence of PV * Embolism Large vegetation \>10mm, persistent infection * Heart Failure Involvement of aortic root, intervalvular fibrosa, pulmonary edema, cardiogenic shock Exclusion Criteria : * Pediatric * Any echocardiographic evidence of absence of IE

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Conditions

The condition(s) this trial relates to.

endocarditis heart failure infective endocarditis

As listed by the trial registrant

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

Heart failure Infective endocarditis

Contacts and locations

Locations

  • Francesco Nappi

    Saint-Denis, France, 93200, France

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