Actively Recruiting

Age: 18Years +
All Genders
NCT07304115

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-26

180

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with an aortic mechanical valve who have consulted from 1995 to date at the reference center.
  • Patients affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • Patients who do not speak French
  • Hearing impaired patients
  • Patients without a phone (interviews will be by phone)
  • Patients who have been individually informed and refuse to participate
  • Patients not affiliated to a social security scheme or universal health coverage
  • Adult patients protected by law
  • Patients receiving state medical aid

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Bichat-Claude Bernard

Paris, France, 75018

Actively Recruiting

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Research Team

A

Annaëlle Lalou

CONTACT

G

Guillaume Jondeau, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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