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Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling (IMPARED)

Primary Purpose

Regurgitation, Mitral

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance Imaging (MRI)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Regurgitation, Mitral focused on measuring Mitral Regurgitation, Myocardial Fibrosis, Surgical Mitral Valve Repair, Cardiac Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
    • 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

Sites / Locations

  • Hôpital Pneumologique et Cardiovasculaire Louis Pradel - Hospices Civils de Lyon - Groupement Hospitalier EstRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Magnetic Resonance Imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Left ventricular volumes
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
Left ventricular volumes
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
left ventricular ejection fraction
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI)
left ventricular ejection fraction
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI
Extracellular volume
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Extracellular volume
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Left ventricular volume
assessed by transthoracic echocardiographic exam
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Left ventricular volume
assessed by transthoracic echocardiographic exam
Left ventricular volume
assessed by transthoracic echocardiographic exam
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Left ventricular volume
assessed by transthoracic echocardiographic exam
end-diastolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
end-systolic diameter in mm
Left ventricular dimension assessed by transthoracic echocardiographic exam
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
Left atrium volume
Left atrium volume are assessed by transthoracic echocardiographic exam
area
area assessed by transthoracic echocardiographic exam
area
area assessed by transthoracic echocardiographic exam
area
area assessed by transthoracic echocardiographic exam
area
area assessed by transthoracic echocardiographic exam
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Mitral annulus diameter
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam
Mitral Regurgitation (MR) residual assessment
Residual MR is assessed by transthoracic echocardiographic exam

Full Information

First Posted
February 25, 2022
Last Updated
August 3, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05284058
Brief Title
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
Acronym
IMPARED
Official Title
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regurgitation, Mitral
Keywords
Mitral Regurgitation, Myocardial Fibrosis, Surgical Mitral Valve Repair, Cardiac Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Magnetic Resonance Imaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cardiac Magnetic Resonance Imaging (MRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of regional myocardial replacement fibrosis after surgery
Description
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.
Time Frame
at 3 months after surgery
Secondary Outcome Measure Information:
Title
Left ventricular volumes
Description
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame
day 0
Title
Left ventricular volumes
Description
Left ventricular volumes assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame
at 3 months after surgery
Title
left ventricular ejection fraction
Description
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame
day 0
Title
left ventricular ejection fraction
Description
Left ventricular function quantification is assessed by left ventricular ejection fraction in %. by Cardiac Magnetic Resonance Imaging (MRI
Time Frame
at 3 months after surgery
Title
Extracellular volume
Description
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame
day 0
Title
Extracellular volume
Description
Extracellular volume is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame
3 months after surgery
Title
Mitral Regurgitation (MR) residual assessment
Description
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame
day 0
Title
Mitral Regurgitation (MR) residual assessment
Description
Residual MR is assessed by Cardiac Magnetic Resonance Imaging (MRI)
Time Frame
at 3 months after surgery
Title
Number of adverse events (AEs)
Description
Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Time Frame
up to 12 months
Title
Number of serious adverse events (SAEs)
Description
Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Time Frame
up to 12 months
Title
New York Heart Association (NYHA) score
Description
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.
Time Frame
at day 0
Title
New York Heart Association (NYHA) score
Description
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.
Time Frame
at discharge from hospital (day 15)
Title
New York Heart Association (NYHA) score
Description
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.
Time Frame
at 1 month after surgery
Title
New York Heart Association (NYHA) score
Description
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.
Time Frame
at 3 months after surgery
Title
New York Heart Association (NYHA) score
Description
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.
Time Frame
at 12 months after surgery
Title
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Description
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.
Time Frame
at day 0
Title
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Description
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.
Time Frame
at discharge from hospital (day 15)
Title
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Description
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.
Time Frame
at 1 month after surgery
Title
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Description
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.
Time Frame
at 3 months after surgery
Title
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Description
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.
Time Frame
at 12 months after surgery
Title
end-diastolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at day 0
Title
end-systolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at day 0
Title
Left ventricular volume
Description
assessed by transthoracic echocardiographic exam
Time Frame
at day 0
Title
end-diastolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at discharge from hospital (day 15)
Title
end-systolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at discharge from hospital (day 15)
Title
Left ventricular volume
Description
assessed by transthoracic echocardiographic exam
Time Frame
at discharge from hospital (day 15)
Title
Left ventricular volume
Description
assessed by transthoracic echocardiographic exam
Time Frame
at 1 month after surgery
Title
end-diastolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at 1 month after surgery
Title
end-systolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at 1 month after surgery
Title
Left ventricular volume
Description
assessed by transthoracic echocardiographic exam
Time Frame
at 12 months after surgery
Title
end-diastolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at 12 months after surgery
Title
end-systolic diameter in mm
Description
Left ventricular dimension assessed by transthoracic echocardiographic exam
Time Frame
at 12 months after surgery
Title
Left atrium volume
Description
Left atrium volume are assessed by transthoracic echocardiographic exam
Time Frame
at day 0
Title
Left atrium volume
Description
Left atrium volume are assessed by transthoracic echocardiographic exam
Time Frame
at discharge from hospital (day 15)
Title
Left atrium volume
Description
Left atrium volume are assessed by transthoracic echocardiographic exam
Time Frame
at 1 month after surgery
Title
Left atrium volume
Description
Left atrium volume are assessed by transthoracic echocardiographic exam
Time Frame
at 12 months after surgery
Title
area
Description
area assessed by transthoracic echocardiographic exam
Time Frame
at day 0
Title
area
Description
area assessed by transthoracic echocardiographic exam
Time Frame
at discharge from hospital (day 15)
Title
area
Description
area assessed by transthoracic echocardiographic exam
Time Frame
at 1 month after surgery
Title
area
Description
area assessed by transthoracic echocardiographic exam
Time Frame
at 12 months after surgery
Title
Mitral annulus diameter
Description
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time Frame
at day 0
Title
Mitral annulus diameter
Description
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time Frame
at discharge from hospital (day 15)
Title
Mitral annulus diameter
Description
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time Frame
at 1 month after surgery
Title
Mitral annulus diameter
Description
Mitral annulus diameter is assessed by transthoracic echocardiographic exam
Time Frame
at 12 months after surgery
Title
Mitral Regurgitation (MR) residual assessment
Description
Residual MR is assessed by transthoracic echocardiographic exam
Time Frame
at day 0
Title
Mitral Regurgitation (MR) residual assessment
Description
Residual MR is assessed by transthoracic echocardiographic exam
Time Frame
at discharge from hospital (day 15)
Title
Mitral Regurgitation (MR) residual assessment
Description
Residual MR is assessed by transthoracic echocardiographic exam
Time Frame
at 1 month after surgery
Title
Mitral Regurgitation (MR) residual assessment
Description
Residual MR is assessed by transthoracic echocardiographic exam
Time Frame
at 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel GRINBERG, Dr
Phone
+33 4 72 35 70 57
Email
daniel.grinberg@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Géraldine SAMSON
Phone
+33 4 27 85 53 26
Email
geraldine.samson@chu-lyon.fr
Facility Information:
Facility Name
Hôpital Pneumologique et Cardiovasculaire Louis Pradel - Hospices Civils de Lyon - Groupement Hospitalier Est
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel GRINBERG, MD
Phone
04 72 35 70 57
Ext
+33
Email
daniel.grinberg.pro@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel GRINBERG, MD

12. IPD Sharing Statement

Learn more about this trial

Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling

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