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Feasibility Study of a Percutaneous Mitral Valve Repair System. (EVEREST(I))

This study has been completed.
Sponsor:
Information provided by:
Evalve
ClinicalTrials.gov Identifier:
NCT00209339
First received: September 13, 2005
Last updated: October 20, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Device: Percutaneous mitral valve repair (MitraClip Implant)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).

Further study details as provided by Evalve:

Primary Outcome Measures:
  • Mitral Regurgitation Severity [ Time Frame: At baseline ]
    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).

  • Mitral Regurgitation Severity [ Time Frame: At discharge or within 30 days of the procedure ]
    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).

  • Mitral Regurgitation Severity [ Time Frame: At 12 months ]
    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).

  • Mitral Regurgitation Severity [ Time Frame: At 24 months ]
    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).

  • Mitral Regurgitation Severity [ Time Frame: At 3 years ]
    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).

  • Mitral Regurgitation Severity [ Time Frame: At 4 years ]
    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).

  • Mitral Regurgitation Severity [ Time Frame: At 5 years ]
    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).

  • Major Adverse Events (MAE) [ Time Frame: Through 30 days ]
    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.

  • Major Adverse Events (MAE) [ Time Frame: Through 6 Months ]
    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.


Secondary Outcome Measures:
  • Procedure Time [ Time Frame: At day 0 (on the day of index procedure) ]

    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 [ Time Frame: At day 0 (on the day of index procedure) ]
    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.

  • Contrast Volume [ Time Frame: At day 0 (on the day of index procedure) ]
    Mean contrast volume utilized during the MitraClip procedure.

  • Fluoroscopy Duration [ Time Frame: At day 0 (on the day of index procedure) ]
    Mean fluoroscopy duration during the MitraClip procedure.

  • Number of Mitraclip Devices Implanted [ Time Frame: At day 0 (on the day of index procedure) ]
  • Intra-procedural Major Adverse Events [ Time Frame: At day 0 (on the day of index procedure) ]
    Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure

  • Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration [ Time Frame: Post index procedure within 30 days ]
  • Post-procedure Hospital Stay [ Time Frame: Post-index procedure until hospital discharge (1 to 19 days) ]
  • Second Intervention to Place a Second MitraClip Device [ Time Frame: Post index procedure through 5 years ]
  • MitraClip Device Embolizations and Single Leaflet Device Attachment [ Time Frame: Post index procedure through 5 years ]
    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.

  • Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) [ Time Frame: At baseline ]
    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.

  • Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) [ Time Frame: At 12 months ]
    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.

  • Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) [ Time Frame: At 24 months ]
    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.

  • Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) [ Time Frame: At 3 Years ]
    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.

  • Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) [ Time Frame: At 4 Years ]
    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.

  • Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) [ Time Frame: At 5 Years ]
    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.

  • Death (Kaplan-Meier Freedom From Death) [ Time Frame: Within 30 days of the procedure ]
  • Death (Kaplan-Meier Freedom From Death) [ Time Frame: At 12 months ]
  • Death (Kaplan-Meier Freedom From Death) [ Time Frame: At 24 months ]
  • Death (Kaplan-Meier Freedom From Death) [ Time Frame: At 3 years ]
  • Death (Kaplan-Meier Freedom From Death) [ Time Frame: At 4 years ]
  • Death (Kaplan-Meier Freedom From Death) [ Time Frame: At 5 years ]
  • Major Vascular and Bleeding Complications [ Time Frame: Through 30 days ]
    Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure

  • Major Vascular and Bleeding Complications [ Time Frame: Through 6 Months ]
    Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure

  • Other Secondary Safety Events [ Time Frame: Through 30 days ]
    Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).

  • Other Secondary Safety Events [ Time Frame: Through 6 months ]
    Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).

  • Left Ventricular End Diastolic Volume [ Time Frame: Baseline ]
    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 [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge) ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 24 months ]
    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 [ Time Frame: 60 months ]
    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 [ Time Frame: Baseline ]
    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 [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge) ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 24 months ]
    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 [ Time Frame: 60 months ]
    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 - Single Orifice [ Time Frame: Baseline ]
    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 - Single Orifice [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge) ]
    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 - Single Orifice [ Time Frame: 12 months ]
    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 - Single Orifice [ Time Frame: 24 months ]
    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 - Single Orifice [ Time Frame: 60 months ]
    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 (MVA) by Pressure Half-Time [ Time Frame: Baseline ]

    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.


  • Mitral Valve Area (MVA) by Pressure Half-Time [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge) ]

    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.


  • Mitral Valve Area (MVA) by Pressure Half-Time [ Time Frame: 12 months ]

    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.


  • Mitral Valve Area (MVA) by Pressure Half-Time [ Time Frame: 24 months ]

    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.


  • Mitral Valve Area (MVA) by Pressure Half-Time [ Time Frame: 60 months ]

    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.


  • Mitral Valve Gradient [ Time Frame: Baseline ]
    Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

  • Mitral Valve Gradient [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge) ]
    Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

  • Mitral Valve Gradient [ Time Frame: 12 months ]
    Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

  • Mitral Valve Gradient [ Time Frame: 24 months ]
    Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

  • Mitral Valve Gradient [ Time Frame: 60 months ]
    Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.

  • Cardiac Output [ Time Frame: Baseline ]
    Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

  • Cardiac Output [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge) ]
    Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

  • Cardiac Output [ Time Frame: 12 months ]
    Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

  • Cardiac Output [ Time Frame: 24 months ]
    Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

  • Cardiac Output [ Time Frame: 60 months ]
    Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.

  • Cardiac Index [ Time Frame: Baseline ]
    Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

  • Cardiac Index [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge) ]
    Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

  • Cardiac Index [ Time Frame: 12 months ]
    Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

  • Cardiac Index [ Time Frame: 24 months ]
    Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

  • Cardiac Index [ Time Frame: 60 months ]
    Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.

  • New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 6 months ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 30 days ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 12 months ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 18 months ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 24 months ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 36 months ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 48 months ]

    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.


  • New York Heart Association (NYHA) Functional Class [ Time Frame: 60 months ]

    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.



Enrollment: 55
Study Start Date: July 2003
Study Completion Date: October 2011
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MitraClip
Percutaneous mitral valve repair (MitraClip Implant)
Device: Percutaneous mitral valve repair (MitraClip Implant)
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.
Other Name: EVEREST I, MitraClip

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209339

Locations
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Evalve
Investigators
Principal Investigator: Ted Feldman, M.D. NorthShore University HealthSystem Research Institute
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth McDermott, Divisional Vice President of Regulatory and Clinical Affairs, Abbott Vascular Structural Heart (Evalve, Inc)
ClinicalTrials.gov Identifier: NCT00209339     History of Changes
Other Study ID Numbers: Protocol #0301 
Study First Received: September 13, 2005
Results First Received: June 21, 2016
Last Updated: October 20, 2016

Keywords provided by Evalve:
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
MR
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

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 17, 2017