Trial Outcomes & Findings for Feasibility Study of a Percutaneous Mitral Valve Repair System. (NCT NCT00209339)

A total of 55 EVEREST I patients were enrolled at 11 sites.The first EVEREST I patient was enrolled on July 2, 2003 and the last patient was enrolled on February 15, 2006.

Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation determined from a transthoracic echocardiogram (TTE), who were candidates for mitral valve (MV) surgery and cardiopulmonary bypass were considered for enrollment in this study.

Feasibility Study of a Percutaneous Mitral Valve Repair System.

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

Mean contrast volume utilized during the MitraClip procedure.

Mean fluoroscopy duration during the MitraClip procedure.

Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure

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.

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.

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.

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.

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.

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.

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.

Major bleeding complications is defined as transfusion of \>=2 units of blood due to bleeding related to the index procedure

Major bleeding complications is defined as transfusion of \>=2 units of blood due to bleeding related to the index procedure

Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).

Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

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.

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.

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.

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.

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.

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.

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.

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.

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.