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Clinical Trials in France / NCT07304115
Recruiting Observational

Noise Associated With a Mechanical Heart Valve Prosthesis: Does the Memory of Preoperative Information Have an Influence on Postoperative Quality of Life?

NCT07304115 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2025-09-03
Last updated
2025-12-26

Condition(s) studied

Mechanical Heart Valve Prosthesis

Study summary

As part of the follow-up in the Day Hospital in the national reference center for Marfan syndrome and related disorders, each consultant benefits from a psychological interview.

During these psychological interviews, it is noticed that some patients with a mechanical heart valve prosthesis are bothered on a daily basis by the noise caused by this valve. Some patients also mention the fact that the noise of their mechanical heart valve prosthesis causes discomfort to their partners.

Indeed, preoperatively to aortic surgery, the need for aortic valve replacement is evaluated and the patient must receive a clear and detailed explanation of the advantages and disadvantages associated with a mechanical heart valve prosthesis and a biological heart valve prosthesis so that he or she can make an informed choice.

Nevertheless, during their psychological interviews, it was noted that the memory of the information concerning the noise associated with mechanical heart valve prostheses is not systematically delivered preoperatively. While there are studies in the literature showing that the noise of the mechanical valve prosthesis has harmful consequences on the quality of life and sleep of the patient and/or those around them, no study has determined whether giving information on the noise associated with the mechanical valve preoperatively will have consequences on the post-operative quality of life of the patient and those around them.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Post-operative quality of life assessed by the answers to the SF36 questionnaire — 1 year
    To determine whether the recall of preoperative information about the noise caused by the mechanical valve has consequences for patients' postoperative quality of life.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Bichat-Claude Bernard Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07304115 on ClinicalTrials.gov ↗ ← All trials in France