Regurgitation, MitralIMPAREDNCT05284058
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
A study testing Cardiac Magnetic Resonance Imaging (MRI) in people with Regurgitation, Mitral, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolapse of at least 2 mm beyond the long-axis mitral annular plane. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regurgitation, Mitral
- What is being tested?
- Cardiac Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2022to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adults (≥ 18 years old)
- Patients candidate for mitral valve repair after validation by the local Heart-Team
- Severe symptomatic primary Mitral Regurgitation (MR), due to:
- Posterior or bileaflet prolapse, with
- Criteria of advance disease (i.e. existence of fibrosis):
- Effective Regurgitant Orifice Area (EROA) > 35 mm2 - Regurgitant volume > 45 mL
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- Left ventricular end-diastolic diameter >55 mm
- Left atrium volume index >60 mL/m2
- Pulmonary artery systolic pressure > 30mmHg
- Patients who have provided written informed consent to participate in the study.
- Patients affiliated with a social health insurance.
Who cannot join
- Patients with contraindication for mitral valve repair, including:
- Patients with secondary MR; and
- Calcified leaflets segments.
- Patients with contraindication for a minimally invasive approach including:
- Previous heart surgery;
- Previous right lung surgery; or
Show all 15Show fewer
- Vascular access contraindications.
- Patients with contraindication for CMR imaging:
- Patients without sinus rhythm
- Regular MRI contraindications (e.g. a claustrophobia, a pacemaker, defibrillator or metallic (ferromagnetic) body, a known allergy to gadolinium)
- Contraindication for Gadolinium infusion: glomerular filtration rate (GFR) <30 ml / min
- Patients unable to understand the purpose of the study
- Patients participating in another trial that would interfere with this study
- Female patients who are pregnant, lactating or women of child-bearing potential without highly effective methods of contraception
- Patients under judicial protection
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pneumologique et Cardiovasculaire Louis Pradel - Hospices Civils de Lyon - Groupement Hospitalier Est
Bron, 69677
About this study
Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolapse of at least 2 mm beyond the long-axis mitral annular plane.
In recent years, several studies have identified a subtype of MVP patients at higher risk of ventricular arrhythmias (VA) and sudden cardiac death (SCD). The presence of regional myocardial replacement fibrosis (RMRF) has been shown as a risk marker of arrhythmic events (VA and SCD) in patients with MVP. RMRF can be identified using cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE+). In these patients, fibrosis was found in the basal inferolateral myocardium and at the level of papillary muscles (PMs). This fibrosis is developed beyond the volume overload related to the MVP. It is probably linked to the mechanical stretch acting upon the valve and the neighboring left ventricle (LV) myocardium. RMRF is associated with a high degree of MR, with specific features of mitral valve apparatus (bi-leaflet prolapse with marked leaflet redundancy, mitral annulus abnormalities (i.e. Mitral-Annular Disjunction)), and more dilated LV. It is also independently associated with the occurrence of cardiovascular events.
Read more
Mitral valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Very little data concerning the impact of preoperative RMRF on mitral valve surgery outcomes is available, and the impact of myocardial fibrosis on the postoperative left ventricle remodeling has not been studied so far.
No previous study compares preoperative and postoperative fibrosis evolution. Thus, no data exists regarding the postoperative evolution of this fibrosis and its relationship with ventricular arrhythmic risk after valve surgery. Small observational studies have suggested that mitral valve surgery did not reduce the risk of ventricular arrhythmias in patients with bileaflet MVP.
Finally, the mechanisms involved in the development of regional myocardial replacement fibrosis within the left ventricle myocardium during the natural history of MVP cannot be understood with current standard medical imaging tools. Numerical simulation technologies provide an innovative and in-vivo approach to assess the physical and pathological mechanisms causing this fibrosis. They can also be used to assess the changes in mitral valve and myocardium dynamics after surgical mitral valve repair procedures.
A large consortium, involving physicians and scientists, has been created to address these questions to fulfil our objectives over a 4 year period (SIMR project).
- Conditions
- Regurgitation, Mitral
- Being tested
- Cardiac Magnetic Resonance Imaging (MRI)
- Keywords
- Mitral Regurgitation, Myocardial Fibrosis, Surgical Mitral Valve Repair, Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance Imaging (MRI)Other
Patients will undergo 2 MRI exams: 1 MRI before surgical intervention (maximum 21 days before) and 1 MRI three months after surgery (+/- 14 days), with intravenous administration of gadolinium.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Magnetic Resonance Imaging | Experimental | All patients who are candidates for surgical mitral valve repair through minimally-invasive access according to the standard of care will be considered for inclusion in this clinical study. All patients will undergo cardiac Magnetic Resonance Imaging (MRI) exam before the surgery, as well as at 3 months follow-up. Receives: Other: Cardiac Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of regional myocardial replacement fibrosis after surgery
Evolution of fibrosis mass within the left ventricle myocardium (assessed as Regional late gadolinium enhancement) on cardiac magnetic resonance (CMR) imaging at 3 months after surgery.
Measured: at 3 months after surgery
Secondary outcomes (48)
Left ventricular volumes
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: day 0
Left ventricular volumes
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: at 3 months after surgery
left ventricular ejection fraction
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI)
Measured: day 0
left ventricular ejection fraction
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI
Measured: at 3 months after surgery
Extracellular volume
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: day 0
Extracellular volume
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: 3 months after surgery
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: day 0
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: at 3 months after surgery
Number of adverse events (AEs)
Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Measured: up to 12 months
Number of serious adverse events (SAEs)
Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Measured: up to 12 months
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: at day 0
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: at discharge from hospital (day 15)
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: at 1 month after surgery
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: at 3 months after surgery
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: at 12 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: at day 0
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: at discharge from hospital (day 15)
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: at 1 month after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: at 3 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: at 12 months after surgery
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at day 0
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at day 0
Left ventricular volume
assessed by transthoracic echocardiographic exam
Measured: at day 0
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at discharge from hospital (day 15)
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at discharge from hospital (day 15)
Left ventricular volume
assessed by transthoracic echocardiographic exam
Measured: at discharge from hospital (day 15)
Left ventricular volume
assessed by transthoracic echocardiographic exam
Measured: at 1 month after surgery
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at 1 month after surgery
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at 1 month after surgery
Left ventricular volume
assessed by transthoracic echocardiographic exam
Measured: at 12 months after surgery
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at 12 months after surgery
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Measured: at 12 months after surgery
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Measured: at day 0
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Measured: at discharge from hospital (day 15)
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Measured: at 1 month after surgery
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Measured: at 12 months after surgery
area
area assessed by transthoracic echocardiographic exam
Measured: at day 0
area
area assessed by transthoracic echocardiographic exam
Measured: at discharge from hospital (day 15)
area
area assessed by transthoracic echocardiographic exam
Measured: at 1 month after surgery
area
area assessed by transthoracic echocardiographic exam
Measured: at 12 months after surgery
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Measured: at day 0
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Measured: at discharge from hospital (day 15)
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Measured: at 1 month after surgery
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Measured: at 12 months after surgery
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Measured: at day 0
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Measured: at discharge from hospital (day 15)
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Measured: at 1 month after surgery
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Measured: at 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start28 Jun 2022
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regurgitation, MitralStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284058
- Sponsor's protocol ID
- 69HCL21_1210
- Other IDs
- ID-RCB
- Acronym
- IMPARED
- Status last verified
- Nov 2024
- First submitted
- 25 Feb 2022
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
- ClinicalTrials.gov ID
- NCT05284058
- Acronym / sponsor ID
- IMPARED / 69HCL21_1210
- Conditions
- Regurgitation, Mitral
- Keywords
- Mitral Regurgitation, Myocardial Fibrosis, Surgical Mitral Valve Repair, Cardiac Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 17 Mar 2022 (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.
Primary mitral regurgitation (MR) is the most common valvular disease in western countries. The MR mechanism is often related to a mitral valve prolapse (MVP) defined as a single or bi-leaflet prolapse of at least 2 mm beyond the long-axis mitral annular plane.
In recent years, several studies have identified a subtype of MVP patients at higher risk of ventricular arrhythmias (VA) and sudden cardiac death (SCD). The presence of regional myocardial replacement fibrosis (RMRF) has been shown as a risk marker of arrhythmic events (VA and SCD) in patients with MVP. RMRF can be identified using cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE+). In these patients, fibrosis was found in the basal inferolateral myocardium and at the level of papillary muscles (PMs). This fibrosis is developed beyond the volume overload related to the MVP. It is probably linked to the mechanical stretch acting upon the valve and the neighboring left ventricle (LV) myocardium. RMRF is associated with a high degree of MR, with specific features of mitral valve apparatus (bi-leaflet prolapse with marked leaflet redundancy, mitral annulus abnormalities (i.e. Mitral-Annular Disjunction)), and more dilated LV. It is also independently associated with the occurrence of cardiovascular events.
Mitral valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Very little data concerning the impact of preoperative RMRF on mitral valve surgery outcomes is available, and the impact of myocardial fibrosis on the postoperative left ventricle remodeling has not been studied so far.
No previous study compares preoperative and postoperative fibrosis evolution. Thus, no data exists regarding the postoperative evolution of this fibrosis and its relationship with ventricular arrhythmic risk after valve surgery. Small observational studies have suggested that mitral valve surgery did not reduce the risk of ventricular arrhythmias in patients with bileaflet MVP.
Finally, the mechanisms involved in the development of regional myocardial replacement fibrosis within the left ventricle myocardium during the natural history of MVP cannot be understood with current standard medical imaging tools. Numerical simulation technologies provide an innovative and in-vivo approach to assess the physical and pathological mechanisms causing this fibrosis. They can also be used to assess the changes in mitral valve and myocardium dynamics after surgical mitral valve repair procedures.
A large consortium, involving physicians and scientists, has been created to address these questions to fulfil our objectives over a 4 year period (SIMR project).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Magnetic Resonance Imaging | Experimental | Other: Cardiac Magnetic Resonance Imaging (MRI)All patients who are candidates for surgical mitral valve repair through minimally-invasive access according to the standard of care will be considered for inclusion in this clinical study. All patients will undergo cardiac Magnetic Resonance Imaging (MRI) exam before the surgery, as well as at 3 months follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults (≥ 18 years old)
- Patients candidate for mitral valve repair after validation by the local Heart-Team
- Effective Regurgitant Orifice Area (EROA) > 35 mm2 - Regurgitant volume > 45 mL
- Left ventricular end-diastolic diameter >55 mm
- Left atrium volume index >60 mL/m2
Key exclusion criteria (15 listed)
- Patients with contraindication for mitral valve repair, including:
- Patients with contraindication for a minimally invasive approach including:
- Patients with contraindication for CMR imaging:
- Patients unable to understand the purpose of the study
- Patients participating in another trial that would interfere with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance Imaging (MRI)Patients will undergo 2 MRI exams: 1 MRI before surgical intervention (maximum 21 days before) and 1 MRI three months after surgery (+/- 14 days), with intravenous administration of gadolinium. | Other | Cardiac Magnetic Resonance Imaging |
Primary outcome
Evolution of regional myocardial replacement fibrosis after surgery
Time frame: at 3 months after surgery
Evolution of fibrosis mass within the left ventricle myocardium (assessed as Regional late gadolinium enhancement) on cardiac magnetic resonance (CMR) imaging at 3 months after surgery.
48 secondary outcomes
Left ventricular volumes
Time frame: day 0
Left ventricular volumes
Time frame: at 3 months after surgery
left ventricular ejection fraction
Time frame: day 0
left ventricular ejection fraction
Time frame: at 3 months after surgery
Extracellular volume
Time frame: day 0
Extracellular volume
Time frame: 3 months after surgery
Mitral Regurgitation (MR) residual assessment
Time frame: day 0
Mitral Regurgitation (MR) residual assessment
Time frame: at 3 months after surgery
Number of adverse events (AEs)
Time frame: up to 12 months
Number of serious adverse events (SAEs)
Time frame: up to 12 months
New York Heart Association (NYHA) score
Time frame: at day 0
New York Heart Association (NYHA) score
Time frame: at discharge from hospital (day 15)
New York Heart Association (NYHA) score
Time frame: at 1 month after surgery
New York Heart Association (NYHA) score
Time frame: at 3 months after surgery
New York Heart Association (NYHA) score
Time frame: at 12 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: at day 0
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: at discharge from hospital (day 15)
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: at 1 month after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: at 3 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: at 12 months after surgery
end-diastolic diameter in mm
Time frame: at day 0
end-systolic diameter in mm
Time frame: at day 0
Left ventricular volume
Time frame: at day 0
end-diastolic diameter in mm
Time frame: at discharge from hospital (day 15)
end-systolic diameter in mm
Time frame: at discharge from hospital (day 15)
Left ventricular volume
Time frame: at discharge from hospital (day 15)
Left ventricular volume
Time frame: at 1 month after surgery
end-diastolic diameter in mm
Time frame: at 1 month after surgery
end-systolic diameter in mm
Time frame: at 1 month after surgery
Left ventricular volume
Time frame: at 12 months after surgery
end-diastolic diameter in mm
Time frame: at 12 months after surgery
end-systolic diameter in mm
Time frame: at 12 months after surgery
Left atrium volume
Time frame: at day 0
Left atrium volume
Time frame: at discharge from hospital (day 15)
Left atrium volume
Time frame: at 1 month after surgery
Left atrium volume
Time frame: at 12 months after surgery
area
Time frame: at day 0
area
Time frame: at discharge from hospital (day 15)
area
Time frame: at 1 month after surgery
area
Time frame: at 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance Imaging (MRI) in people with Regurgitation, Mitral, run by Hospices Civils de Lyon 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 11 inclusion and 15 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: finished, as of the sponsor's last update on 2 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of regional myocardial replacement fibrosis after surgery (time frame: at 3 months after surgery). 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 2 Dec 2024.