Does remembering pre-surgery information about mechanical valve noise affect quality of life after valve replacement?
Noise Associated With a Mechanical Heart Valve Prosthesis: Does the Memory of Preoperative Information Have an Influence on Postoperative Quality of Life?
See if remembering the pre-surgery explanation about mechanical valve noise changes how bothered adults with Marfan syndrome and an aortic mechanical valve feel afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07304115 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with Marfan syndrome who had an aortic mechanical valve and who consulted at Hôpital Bichat since 1995, who speak French, have phone access, and are covered by French social security are ideal candidates.
Not a fit: Patients who are hearing impaired, do not speak French, lack a phone, or are not affiliated with French social security (including AME recipients) are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians improve preoperative counseling so fewer patients are surprised or distressed by mechanical valve noise, potentially improving postoperative quality of life.
How similar studies have performed: Existing literature documents that mechanical valve noise often harms quality of life, but few studies have specifically tested whether remembering preoperative information changes that outcome.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- Hôpital Bichat-Claude Bernard — Paris, France (Recruiting)
Study contacts
- Study coordinator: Annaëlle Lalou
- Email: annaelle.lalou@aphp.fr
- Phone: 01.40.25.63.36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.