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RECRUITING
NCT07304115

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2025-09-03

Completion Date

2026-09-03

Last Updated

2025-12-26

Healthy Volunteers

No

Locations (1)

Hôpital Bichat-Claude Bernard

Paris, France