Feasibility Study of a Percutaneous Mitral Valve Repair System.

Study Overview
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Brief Summary
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Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.

Detailed Description
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Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System. The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month clinical follow-up. Up to 12 clinical sites throughout the US may participate. The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of reduction of MR.

Official Title
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A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).

Conditions
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Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency

Intervention / Treatment
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* Device: Percutaneous mitral valve repair (MitraClip Implant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction; Experience regurgitation origination from the central two-thirds of the valve; Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass. Exclusion Criteria: Ejection fraction < 30% Endocarditis Rheumatic heart disease Renal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MitraClip<br>Percutaneous mitral valve repair (MitraClip Implant) | Device: Percutaneous mitral valve repair (MitraClip Implant)<br>* Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.<br>* Other names: EVEREST I, MitraClip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At baseline | 
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At discharge or within 30 days of the procedure | 
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 12 months | 
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 24 months | 
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 3 years | 
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 4 years | 
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 5 years | 
| Major Adverse Events (MAE) | Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia. | Through 30 days | 
| Major Adverse Events (MAE) | Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia. | Through 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Time | Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours. The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device. | At day 0 (on the day of index procedure) | 
| Device Time | Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC. | At day 0 (on the day of index procedure) | 
| Contrast Volume | Mean contrast volume utilized during the MitraClip procedure. | At day 0 (on the day of index procedure) | 
| Fluoroscopy Duration | Mean fluoroscopy duration during the MitraClip procedure. | At day 0 (on the day of index procedure) | 
| Number of Mitraclip Devices Implanted |  | At day 0 (on the day of index procedure) | 
| Intra-procedural Major Adverse Events | Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure | At day 0 (on the day of index procedure) | 
| Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration |  | Post index procedure within 30 days | 
| Post-procedure Hospital Stay |  | Post-index procedure until hospital discharge (1 to 19 days) | 
| Second Intervention to Place a Second MitraClip Device |  | Post index procedure through 5 years | 
| MitraClip Device Embolizations and Single Leaflet Device Attachment | MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device. | Post index procedure through 5 years | 
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At baseline | 
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 12 months | 
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 24 months | 
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 3 Years | 
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 4 Years | 
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 5 Years | 
| Death (Kaplan-Meier Freedom From Death) |  | Within 30 days of the procedure | 
| Death (Kaplan-Meier Freedom From Death) |  | At 12 months | 
| Death (Kaplan-Meier Freedom From Death) |  | At 24 months | 
| Death (Kaplan-Meier Freedom From Death) |  | At 3 years | 
| Death (Kaplan-Meier Freedom From Death) |  | At 4 years | 
| Death (Kaplan-Meier Freedom From Death) |  | At 5 years | 
| Major Vascular and Bleeding Complications | Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure | Through 30 days | 
| Major Vascular and Bleeding Complications | Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure | Through 6 Months | 
| Other Secondary Safety Events | Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major). | Through 30 days | 
| Other Secondary Safety Events | Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major). | Through 6 months | 
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | Baseline | 
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) | 
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | 12 months | 
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | 24 months | 
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | 60 months | 
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | Baseline | 
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) | 
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | 12 months | 
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | 24 months | 
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | 60 months | 
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | Baseline | 
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) | 
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | 12 months | 
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | 24 months | 
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | 60 months | 
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | Baseline | 
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) | 
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | 12 months | 
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | 24 months | 
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | 60 months | 
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | Baseline | 
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) | 
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | 12 months | 
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | 24 months | 
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | 60 months | 
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | Baseline | 
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) | 
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | 12 months | 
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | 24 months | 
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | 60 months | 
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | Baseline | 
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) | 
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | 12 months | 
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | 24 months | 
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | 60 months | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | Baseline | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 6 months | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 30 days | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 12 months | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 18 months | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 24 months | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 36 months | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 48 months | 
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MR, Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, Mitral Valve Prolapse, E2E - Edge to Edge, Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, CAD - Coronary Artery Disease, Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II