Mechanical Heart Valve ProsthesisQUALICLICNCT07304115
Noise Associated With a Mechanical Heart Valve Prosthesis: Does the Memory of Preoperative Information Have an Influence on Postoperative Quality of Life?
An observational study of Mechanical Heart Valve Prosthesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Heart Valve Prosthesis
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2025to 3 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of legal age and implanted with an aortic mechanical valve.
Who may be able to join
- Patients with an aortic mechanical valve who have consulted from 1995 to date at the reference center.
- Patients affiliated to a social security scheme
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guillaume Jondeau, MD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Bichat-Claude Bernard
Paris, 75018
Annaëlle Lalou, 01.40.25.63.36, annaelle.lalou@aphp.fr
About this study
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.
Read more
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.
Read the detailed description
During cardiac surgery in people with Marfan Syndrome, it is not uncommon for an aortic or mitral valve replacement to be performed. Several types of valve substitutes exist, each with its advantages and disadvantages: biological valve prostheses made with animal tissue and mechanical valve prostheses made of synthetic materials (pyrolytic carbon and titanium) are mainly implanted.
Heart valve surgery is necessary on average before the age of 40 in Marfan syndrome, i.e. at a younger age than in other heart valve pathologies.
The recommendations are to prefer a mechanical valve prosthesis in subjects under 60 years of age because these mechanical prostheses have a longer lifespan than biological prostheses, especially in young subjects. However, the implantation of a mechanical valve prosthesis has two main disadvantages compared to the biological prosthesis:
- the need to take anticoagulant treatment with Anti Vitamin K for life
- the noise generated by the wings of the mechanical prosthesis when they close
Data from the literature confirm that this noise is potentially harmful to patients' quality of life, since one to three-quarters of patients are regularly bothered by the noise generated by the mechanical prosthesis and that this noise can disturb patients during the day but also during their sleep. However, it appears that most patients are not informed preoperatively that a mechanical prosthesis generates a noise that they will be able to hear.
A study that involved nearly 1200 patients with mechanical prostheses reported that valve noise is felt more negatively in women and patients under 60 years of age.
Based on data from the literature, it appears that the noise generated by mechanical valves can be harmful to some patients and impact the quality of life of some patients.
On the other hand, the frequency and effect on quality of life of providing information to the patient preoperatively on the advantages and disadvantages of the different types of valve replacement has not been studied, or very little.
This study wants to determine whether the recall of preoperative information about the noise caused by the mechanical valve has consequences on the postoperative quality of life of patients.
- Conditions
- Mechanical Heart Valve Prosthesis
- Keywords
- mechanical heart valve prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an aortic mechanical valve who have consulted at the Marfan reference center | All adult patients with an aortic mechanical valve who have consulted at the Marfan reference center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative quality of life assessed by the answers to the SF36 questionnaire
To determine whether the recall of preoperative information about the noise caused by the mechanical valve has consequences for patients' postoperative quality of life.
Measured: 1 year
Secondary outcomes (7)
Gender (male)
Determine whether being a male is a determinant of discomfort related to mechanical valve noise.
Measured: 1 year
Gender (female)
Determine whether being a female is a determinant of discomfort related to mechanical valve noise.
Measured: 1 year
Percentage of patients who would have chosen not to receive mechanical valves
To determine whether recalling preoperative noise information would have changed the patient's choice of valve replacement type.
Measured: 1 year
Operation in an emergency
Comparison between patients who were operated on in an emergency and those who were operated on during scheduled surgery to determine the impact of emergency surgery compared to scheduled surgery on the discomfort caused by mechanical valve noise.
Measured: 1 year
Scheduled surgery
Comparison between patients who were operated on in an emergency and those who were operated on during scheduled surgery to determine the impact of emergency surgery compared to scheduled surgery on the discomfort caused by mechanical valve noise.
Measured: 1 year
Patients who were operated on before 2004
Comparison to determine whether there is a significant difference in responses between patients who have had surgery more than 20 years ago (before the year 2004) and those who have had surgery in the last 20 years.
Measured: 1 year
Patients who were operated on after 2004
Comparison to determine whether there is a significant difference in responses between patients who have had surgery more than 20 years ago (before the year 2004) and those who have had surgery in the last 20 years.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start3 Sep 2025
- Primary completion3 Sep 2026 (estimated)
- Study completion3 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Heart Valve ProsthesisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304115
- Sponsor's protocol ID
- APHP240701
- Other IDs
- 2024-A01122-45
- Acronym
- QUALICLIC
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise Associated With a Mechanical Heart Valve Prosthesis: Does the Memory of Preoperative Information Have an Influence on Postoperative Quality of Life?
- ClinicalTrials.gov ID
- NCT07304115
- Acronym / sponsor ID
- QUALICLIC / APHP240701
- Conditions
- Mechanical Heart Valve Prosthesis
- Keywords
- mechanical heart valve prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 3 Sep 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During cardiac surgery in people with Marfan Syndrome, it is not uncommon for an aortic or mitral valve replacement to be performed. Several types of valve substitutes exist, each with its advantages and disadvantages: biological valve prostheses made with animal tissue and mechanical valve prostheses made of synthetic materials (pyrolytic carbon and titanium) are mainly implanted.
Heart valve surgery is necessary on average before the age of 40 in Marfan syndrome, i.e. at a younger age than in other heart valve pathologies.
The recommendations are to prefer a mechanical valve prosthesis in subjects under 60 years of age because these mechanical prostheses have a longer lifespan than biological prostheses, especially in young subjects. However, the implantation of a mechanical valve prosthesis has two main disadvantages compared to the biological prosthesis:
- the need to take anticoagulant treatment with Anti Vitamin K for life
- the noise generated by the wings of the mechanical prosthesis when they close
Data from the literature confirm that this noise is potentially harmful to patients' quality of life, since one to three-quarters of patients are regularly bothered by the noise generated by the mechanical prosthesis and that this noise can disturb patients during the day but also during their sleep. However, it appears that most patients are not informed preoperatively that a mechanical prosthesis generates a noise that they will be able to hear.
A study that involved nearly 1200 patients with mechanical prostheses reported that valve noise is felt more negatively in women and patients under 60 years of age.
Based on data from the literature, it appears that the noise generated by mechanical valves can be harmful to some patients and impact the quality of life of some patients.
On the other hand, the frequency and effect on quality of life of providing information to the patient preoperatively on the advantages and disadvantages of the different types of valve replacement has not been studied, or very little.
This study wants to determine whether the recall of preoperative information about the noise caused by the mechanical valve has consequences on the postoperative quality of life of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an aortic mechanical valve who have consulted at the Marfan reference center | – | –All adult patients with an aortic mechanical valve who have consulted at the Marfan reference center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of legal age and implanted with an aortic mechanical valve.
Key inclusion criteria (2 listed)
- Patients with an aortic mechanical valve who have consulted from 1995 to date at the reference center.
- Patients affiliated to a social security scheme
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative quality of life assessed by the answers to the SF36 questionnaire
Time frame: 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.
7 secondary outcomes
Gender (male)
Time frame: 1 year
Gender (female)
Time frame: 1 year
Percentage of patients who would have chosen not to receive mechanical valves
Time frame: 1 year
Operation in an emergency
Time frame: 1 year
Scheduled surgery
Time frame: 1 year
Patients who were operated on before 2004
Time frame: 1 year
Patients who were operated on after 2004
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Jondeau, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Heart Valve Prosthesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annaëlle Lalou (01.40.25.63.36, annaelle.lalou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative quality of life assessed by the answers to the SF36 questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.