Does remembering pre-surgery information about mechanical valve noise affect quality of life after valve replacement?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational follow-up of adults with Marfan syndrome who received an aortic mechanical valve and who have been seen at the national reference center since 1995. Researchers will use psychological records, chart review, and phone interviews to document patients' recall of preoperative counseling about valve noise and their current postoperative experience, including sleep disturbance and daily bother. Patients who are hearing impaired, non–French-speaking, lack phone access, or are not covered by French social security are excluded. The goal is to link memory of preoperative information to reported quality-of-life impacts related to mechanical valve noise and to inform future preoperative counseling.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with an aortic mechanical valve who have consulted from 1995 to date at the reference center.
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Patient who does not speak French
* Hearing or hearing impaired patient.
* Patient without a phone: Interviews will take place over the phone.
* Patient who has been individually informed and objects to participate in this research
* Patient not affiliated to a social security scheme or CMU (Universal health coverage)
* Adult patients protected by law
* Patient on AME (State medical aid)

Where it's running

• Hôpital Bichat-Claude Bernard
  Paris, France Recruiting

Study contacts

• Study coordinator: Annaëlle Lalou
• Email: annaelle.lalou@aphp.fr
• Phone: 01.40.25.63.36

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.