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

NCT07304115 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-12-26

No results posted yet for this 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.

Conditions

  • Mechanical Heart Valve Prosthesis

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2026-09-03
Completion
2026-09-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304115 on ClinicalTrials.gov