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Heart valve mismatch mystery: does it really matter after surgery?

NCT ID NCT00854698

Knowledge-focused Sponsor: University Hospital, Strasbourg, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 77 patients under 60 who had a mechanical aortic valve replacement to see if a mismatch between the valve size and the patient's body affects heart recovery and exercise ability. Participants did exercise tests and heart ultrasounds years after surgery. The goal is to settle a debate about whether valve mismatch truly impacts long-term heart function and quality of life.

What this could mean

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

Active substance
exercise training
What this could lead to
If successful, this could clarify whether aortic valve mismatch after replacement truly limits exercise capacity and heart recovery, guiding future treatment decisions.
What could go wrong
This is a small, completed observational study with only 77 participants, so results may not apply to all patients. It does not test a new treatment, so no direct benefit is expected.

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

77 people

The number who actually took part.

Start date

Jun 2009

Finished

Apr 2014

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 to 60 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: * Patient major ≤ 60 years at the time of the aortic valve replacement. * Patient affiliated with a social security * Consent dated and signed by the investigator and the subject * Subject having been informed of the results of the visit prior aortic valve replacement by mechanical prosthesis for pure aortic narrowing. * Fraction left ventricular ejection ≥ 50%, when aortic valve replacement and at the time of inclusion. * Aortic insufficiency at aortic valve replacement associated \<II / IV. * aortic valve replacement exclusive (no gestures associated: coronary bypass, enlargement of the ring, another valve surgery,…). * Coronarography normal at the aortic valve replacement. * Normal renal function. * No history of heart failure episode in the previous month inclusion. * No indication against a stress test on bicycle ergometric Exclusion Criteria: * Refusal of the patient to be included in the study. * History of cardiac surgery under extra body movement before and / or after the aortic valve replacement. * Aortic insufficiency associated with the time of the transaction\> II / IV. * Chronic respiratory insufficiency. * Track cancer or cancer evolving. * Evolutionary Osteoarthritis of the lower limbs or widespread. * Myopathy device. * Alteration higher making it impossible to carry out the test effort and response to the questionnaire on the quality of life. * Coronaropathy documented.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

The left ventricular remodeling after mechanical aortic valve replacement

Contacts and locations

Locations

  • CHRU, Nouvel Hôpital Civil, Service de chirurgie cardio-vasculaire

    Strasbourg, France

More trials for these conditions

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