Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DEVICEPercutaneous 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.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mitral Regurgitation Severity | 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). |
| Major Adverse Events (MAE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Volume | At day 0 (on the day of index procedure) | Mean contrast volume utilized during the MitraClip procedure. |
| Fluoroscopy Duration | At day 0 (on the day of index procedure) | Mean fluoroscopy duration during the MitraClip procedure. |
| Number of Mitraclip Devices Implanted | At day 0 (on the day of index procedure) | — |
| Intra-procedural Major Adverse Events | 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 | 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 | 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) | 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. |
| Death (Kaplan-Meier Freedom From Death) | Within 30 days of the procedure | — |
| Procedure Time | 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. |
| Other Secondary Safety Events | Through 30 days | Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major). |
| Left Ventricular End Diastolic Volume | 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 Systolic Volume | 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. |
| Mitral Valve Area - Single Orifice | 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 (MVA) by Pressure Half-Time | 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 Gradient | Baseline | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. |
| Cardiac Output | Baseline | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. |
| Cardiac Index | Baseline | 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 | 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. |
| Major Vascular and Bleeding Complications | Through 30 days | Major bleeding complications is defined as transfusion of \>=2 units of blood due to bleeding related to the index procedure |
| Device Time | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| At 12 Months Follow-up | Death | 1 |
| At 12 Months Follow-up | No MitraClip Device Implanted | 6 |
| At 12 Months Follow-up | Withdrawal by Subject | 8 |
| At 24 Months Follow-up | Death | 1 |
| At 24 Months Follow-up | Withdrawal because of other reasons | 6 |
| At 24 Months Follow-up | Withdrawal by Subject | 4 |
| At 3 Years Follow-up | Withdrawal by Subject | 1 |
| At 4 Years Follow-up | Death | 1 |
| At 4 Years Follow-up | Withdrawal by Subject | 4 |
| At 5 Years Follow-up | Death | 1 |
| At 5 Years Follow-up | Withdrawal because of other reasons | 5 |
| At 5 Years Follow-up | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Percutaneous Mitral Valve Repair (MitraClip Implant) |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 52 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 43 / 55 |
| serious Total, serious adverse events | 36 / 55 |
Outcome results
Primary
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.
Time frame: Through 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Death | 0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Myocardial Infarction | 0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Cardiac Tamponade | 1.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Cardiac Surgery for failed MitraClip Device | 1.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Single Leaflet Device Attachment (SLDA) | 7.2 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Stroke | 3.6 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Septicemia | 0 Percentage of participants |
Primary
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.
Time frame: Through 6 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Cardiac Tamponade | 1.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Death | 1.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Myocardial Infarction | 1.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Cardiac Surgery for failed MitraClip Device | 1.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Single Leaflet Device Attachment (SLDA) | 7.2 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Stroke | 3.6 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Adverse Events (MAE) | Septicemia | 1.8 Percentage of participants |
Primary
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).
Time frame: At 5 years
Population: Of total 55 patients population 15 patients were analysed, as 40 patients were withdrawn or lost to follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 0+:None | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 1+:Mild | 26.7 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 2+:Moderate | 46.7 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 3+:Moderate-to-Severe | 26.7 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 4+:Severe | 0.0 Percentage of participants |
Primary
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).
Time frame: At discharge or within 30 days of the procedure
Population: Based on the number of patients who have not died or withdrawn, and have reached the scheduled visit window
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 0+:None | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 1+:Mild | 62.5 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 2+:Moderate | 20.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 3+:Moderate-to-Severe | 14.6 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 4+:Severe | 2.1 Percentage of participants |
Primary
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).
Time frame: At 12 months
Population: Of total 55 patients population 39 patients were analyzed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 0+:None | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 1+:Mild | 35.9 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 2+:Moderate | 35.9 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 3+:Moderate-to-Severe | 17.9 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 4+:Severe | 10.3 Percentage of participants |
Primary
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).
Time frame: At 24 months
Population: Of total 55 patients population 28 patients were analysed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 0+:None | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 1+:Mild | 42.9 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 2+:Moderate | 42.9 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 3+:Moderate-to-Severe | 7.1 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 4+:Severe | 7.1 Percentage of participants |
Primary
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).
Time frame: At 3 years
Population: Of total 55 patients population 23 patients were analysed, as for 5 patients Echocardiogram was not performed and 27 patients were withdrawn or lost to follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 0+:None | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 1+:Mild | 39.1 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 2+:Moderate | 39.1 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 3+:Moderate-to-Severe | 13 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 4+:Severe | 8.7 Percentage of participants |
Primary
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).
Time frame: At 4 years
Population: Of total 55 patients population 19 patients were analysed, as for 4 patients Echocardiogram was not performed and 32 patients were withdrawn or lost to follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 0+:None | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 1+:Mild | 26.3 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 2+:Moderate | 47.4 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 3+:Moderate-to-Severe | 21.1 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 4+:Severe | 5.3 Percentage of participants |
Primary
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).
Time frame: At baseline
Population: Of total 55 patients,for 1 patient Echocardiogram was not evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 0+:None | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 1+:Mild | 0.0 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 2+:Moderate | 5.6 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 3+:Moderate-to-Severe | 38.9 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Regurgitation Severity | 4+:Severe | 55.6 Percentage of participants |
Secondary
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Index | 2.5 L/min/m^2 |
Secondary
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time frame: 24 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Index | 2.3 L/min/m^2 |
Secondary
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time frame: 12 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Index | 2.2 L/min/m^2 |
Secondary
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time frame: Baseline
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Index | 2.0 L/min/m^2 |
Secondary
Cardiac Index
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.
Time frame: 60 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Index | 2.1 L/min/m^2 |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Output | 4.7 L/min |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 12 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Output | 4.2 L/min |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 60 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Output | 3.7 L/min |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: 24 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Output | 4.2 L/min |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.
Time frame: Baseline
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Cardiac Output | 3.7 L/min |
Secondary
Contrast Volume
Mean contrast volume utilized during the MitraClip procedure.
Time frame: At day 0 (on the day of index procedure)
Population: Contrast volume was not recorded in one patient. Therefore, contrast volume data is available for 54 of the 55 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Contrast Volume | 112.0 Milliliters | Standard Deviation 54.8 |
Secondary
Death (Kaplan-Meier Freedom From Death)
Time frame: At 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Death (Kaplan-Meier Freedom From Death) | 97.7 Percentage of participants |
Secondary
Death (Kaplan-Meier Freedom From Death)
Time frame: At 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Death (Kaplan-Meier Freedom From Death) | 95 Percentage of participants |
Secondary
Death (Kaplan-Meier Freedom From Death)
Time frame: At 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Death (Kaplan-Meier Freedom From Death) | 86.4 Percentage of participants |
Secondary
Death (Kaplan-Meier Freedom From Death)
Time frame: At 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Death (Kaplan-Meier Freedom From Death) | 91.5 Percentage of participants |
Secondary
Death (Kaplan-Meier Freedom From Death)
Time frame: At 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Death (Kaplan-Meier Freedom From Death) | 95 Percentage of participants |
Secondary
Death (Kaplan-Meier Freedom From Death)
Time frame: Within 30 days of the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Death (Kaplan-Meier Freedom From Death) | 100 Percentage of participants |
Secondary
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.
Time frame: At day 0 (on the day of index procedure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Device Time | 198.5 Minutes | Standard Deviation 99.2 |
Secondary
Fluoroscopy Duration
Mean fluoroscopy duration during the MitraClip procedure.
Time frame: At day 0 (on the day of index procedure)
Population: Mean fluoroscopy duration was not recorded in one patient. Therefore, mean fluoroscopy data is available for 54 of the 55 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Fluoroscopy Duration | 59.8 Minutes | Standard Deviation 31.4 |
Secondary
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
Time frame: At day 0 (on the day of index procedure)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Intra-procedural Major Adverse Events | Death | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Intra-procedural Major Adverse Events | Myocardial Infarction | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Intra-procedural Major Adverse Events | Cardiac Tamponade | 1.8 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Intra-procedural Major Adverse Events | Cardiac Surgery for failed MitraClip Device | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Intra-procedural Major Adverse Events | Single Leaflet Device Attachment (SLDA) | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Intra-procedural Major Adverse Events | Stroke | 1.8 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Intra-procedural Major Adverse Events | Septicemia | 0.0 percentage of participants |
Secondary
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.
Time frame: 12 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Diastolic Volume | 149.9 Milliliter |
Secondary
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.
Time frame: Baseline
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Diastolic Volume | 169.0 Milliliter |
Secondary
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.
Time frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Diastolic Volume | 154.8 Milliliter |
Secondary
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.
Time frame: 24 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Diastolic Volume | 131.4 Milliliter |
Secondary
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.
Time frame: 60 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Diastolic Volume | 107.0 Milliliter |
Secondary
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.
Time frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Systolic Volume | 67.4 Milliliter |
Secondary
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.
Time frame: Baseline
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Systolic Volume | 67.0 Milliliter |
Secondary
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.
Time frame: 24 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Systolic Volume | 55.8 Milliliter |
Secondary
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.
Time frame: 12 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Systolic Volume | 62.8 Milliliter |
Secondary
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.
Time frame: 60 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Left Ventricular End Systolic Volume | 40.4 Milliliter |
Secondary
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
Time frame: Through 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Vascular and Bleeding Complications | Major Vascular Complication | 5.5 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Vascular and Bleeding Complications | Major Bleeding Complication | 5.5 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Vascular and Bleeding Complications | Non-Cerebral Thromboembolism | 0.0 percentage of participants |
Secondary
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
Time frame: Through 6 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Vascular and Bleeding Complications | Major Vascular Complication | 7.3 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Vascular and Bleeding Complications | Major Bleeding Complication | 5.5 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Major Vascular and Bleeding Complications | Non-Cerebral Thromboembolism | 0.0 percentage of participants |
Secondary
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.
Time frame: Post index procedure through 5 years
Population: Of the 55 patients enrolled in the EVEREST I study, 6 patients did not have a MitraClip device implanted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | MitraClip Device Embolizations and Single Leaflet Device Attachment | MitraClip device embolizations | 0 Participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | MitraClip Device Embolizations and Single Leaflet Device Attachment | Single Leaflet Device Attachment | 5 Participants |
Secondary
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.
Time frame: Baseline
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area (MVA) by Pressure Half-Time | 4.2 cm^2 |
Secondary
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.
Time frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area (MVA) by Pressure Half-Time | 3.0 cm^2 |
Secondary
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.
Time frame: 12 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area (MVA) by Pressure Half-Time | 2.7 cm^2 |
Secondary
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.
Time frame: 24 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area (MVA) by Pressure Half-Time | 2.8 cm^2 |
Secondary
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.
Time frame: 60 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area (MVA) by Pressure Half-Time | 2.8 cm^2 |
Secondary
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.
Time frame: 60 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area - Single Orifice | 3.3 cm^2 |
Secondary
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.
Time frame: Baseline
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area - Single Orifice | 6.1 cm^2 |
Secondary
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.
Time frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area - Single Orifice | 3.7 cm^2 |
Secondary
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.
Time frame: 12 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area - Single Orifice | 3.6 cm^2 |
Secondary
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.
Time frame: 24 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Area - Single Orifice | 3.4 cm^2 |
Secondary
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time frame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Gradient | 3.9 mmHg |
Secondary
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time frame: 12 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Gradient | 3.5 mmHg |
Secondary
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time frame: 24 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Gradient | 3.7 mmHg |
Secondary
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time frame: 60 months
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Gradient | 3.6 mmHg |
Secondary
Mitral Valve Gradient
Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.
Time frame: Baseline
Population: Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Gradient | 1.7 mmHg |
Secondary
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.
Time frame: At baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | 100 Percentage of participants |
Secondary
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.
Time frame: At 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | 74.4 Percentage of participants |
Secondary
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.
Time frame: At 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | 68.2 Percentage of participants |
Secondary
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.
Time frame: At 3 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | 63.6 Percentage of participants |
Secondary
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.
Time frame: At 4 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | 61.2 Percentage of participants |
Secondary
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.
Time frame: At 5 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | 55.1 Percentage of participants |
Secondary
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.
Time frame: 30 days
Population: NYHA functional class was evaluated in 47 patients at the 30-day follow-up visit. NYHA assessment is missing in 8 patients due to:~* 2 withdrawals~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 27 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 17 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 3 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 participants |
Secondary
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.
Time frame: 18 months
Population: NYHA functional class was evaluated in 27 patients at the 18-month follow-up visit. NYHA assessment is missing in 28 patients due to:~* 15 withdrawals~* 2 deaths~* 5 missed visits~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 15 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 10 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 1 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 1 participants |
Secondary
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.
Time frame: 36 months
Population: NYHA functional class was evaluated in 21 patients at the 36-month follow-up visit. NYHA assessment is missing in 34 patients due to:~* 19 withdrawals~* 2 deaths~* 3 missed visits~* 4 NYHA assessments not done~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 8 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 10 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 3 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 participants |
Secondary
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.
Time frame: 24 months
Population: NYHA functional class was evaluated in 28 patients at the 24-month follow-up visit. NYHA assessment is missing in 27 patients due to:~* 18 withdrawals~* 2 deaths~* 1 missed visit~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 15 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 12 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 1 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 participants |
Secondary
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.
Time frame: 48 months
Population: NYHA functional class was evaluated in 19 patients at the 48-month follow-up visit. NYHA assessment is missing in 36 patients due to:~* 23 withdrawals~* 3 deaths~* 1 missed visit~* 3 NYHA assessments not done~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 6 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 11 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 2 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 participants |
Secondary
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.
Time frame: 60 months
Population: NYHA functional class was evaluated in 15 patients at the 48-month follow-up visit. NYHA assessment is missing in 40 patients due to:~* 30 withdrawals~* 4 deaths~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 5 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 9 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 1 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 participants |
Secondary
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.
Time frame: 12 months
Population: NYHA functional class was evaluated in 39 patients at the 12-month follow-up visit. NYHA assessment is missing in 16 patients due to:~* 8 withdrawals~* 1 death~* NYHA assessment not done in 1 patient~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 19 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 17 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 3 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 participants |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 4 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 24 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 24 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 3 participants |
Secondary
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.
Time frame: 6 months
Population: NYHA functional class was evaluated in 41 patients at the 6-month follow-up visit. NYHA assessment is missing in 14 patients due to:~* 7 withdrawals~* 1 death~* As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 20 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 17 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 4 participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 participants |
Secondary
Number of Mitraclip Devices Implanted
Time frame: At day 0 (on the day of index procedure)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Number of Mitraclip Devices Implanted | 0 | 10.9 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Number of Mitraclip Devices Implanted | 1 | 61.8 Percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Number of Mitraclip Devices Implanted | 2 | 27.3 Percentage of participants |
Secondary
Other Secondary Safety Events
Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).
Time frame: Through 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | Endocarditis | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | MitraClip Device Thrombosis | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | Hemolysis | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | Mitral Valve Injury (major) | 3.6 percentage of participants |
Secondary
Other Secondary Safety Events
Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).
Time frame: Through 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | Endocarditis | 1.8 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | MitraClip Device Thrombosis | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | Hemolysis | 0.0 percentage of participants |
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Other Secondary Safety Events | Mitral Valve Injury (major) | 3.6 percentage of participants |
Secondary
Post-procedure Hospital Stay
Time frame: Post-index procedure until hospital discharge (1 to 19 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Post-procedure Hospital Stay | 2.9 Days | Standard Deviation 3.5 |
Secondary
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration
Time frame: Post index procedure within 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration | 56.7 Hours | Standard Deviation 80.2 |
Secondary
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.
Time frame: At day 0 (on the day of index procedure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Procedure Time | 254.7 Minutes | Standard Deviation 105.1 |
Secondary
Second Intervention to Place a Second MitraClip Device
Time frame: Post index procedure through 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percutaneous Mitral Valve Repair (MitraClip Implant) | Second Intervention to Place a Second MitraClip Device | 2 Participants |