Mitral Regurgitation
Conditions
Keywords
Mitral Valve, Annuloplasty
Brief summary
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
Interventions
DEVICECardioband
Sponsors
Edwards Lifesciences
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
* Age \> 18 years * Moderate to severe functional Mitral Regurgitation (MR) * Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated. * Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm * Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site) * Transseptal catheterization and femoral vein access is determined to be feasible * Subject is able and willing to give informed consent and follow protocol procedures
Exclusion criteria
* Active bacterial endocarditis * Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue * Heavily calcified annulus or leaflets * Subjects in whom transesophageal echocardiography is contraindicated * Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization * CRT implant within 3 months prior to procedure * Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months * Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (\>70% by Ultra sound) * Renal insufficiency requiring dialysis * Life expectancy of less than twelve months * Subject is participating in concomitant research studies of investigational products * Mitral valve anatomy which may preclude proper device treatment * Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | 30 days | Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance [MLHFQ] | Baseline, 6 and 12 months | Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life. |
| Performance [6MWT] | Baseline, 6 and 12 months | Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months. |
| Performance [Intra-subject Comparison - MR Severity] | Baseline, discharge, 6 and 12 months | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). |
| Performance [Full Analysis Data Set - MR Severity] | Baseline, discharge, 6 and 12 months | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate of the Implantation of the Cardioband | Immediately after implantation | The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System. |
| Technical Feasibility of Cardioband Adjustment | Immediately after procedure | The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire. |
| Reduce MR [Paired Baseline and Follow-Up] | Post-adjustment, discharge, and 30 Days | Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1. |
Countries
France, Germany, Israel, Italy, Netherlands, Switzerland
Participant flow
Pre-assignment details
Of 62 patients originally enrolled, 1 excluded from full analysis data set (N=61) but included in safety analysis data set (N=62). Patient had severe MR, right heart failure (RHF), and tricuspid regurgitation (TR); determined to be a significant deviation from intended use of device. Study protocol amended to exclude severe RHF and TR.
Participants by arm
| Arm | Count |
|---|---|
| Single Multi-center, prospective study with intra-subject comparisons | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Discontinued Follow Up | 5 |
| Overall Study | No Implantation | 1 |
| Overall Study | Study exit due to secondary intervention | 6 |
Baseline characteristics
| Characteristic | Single |
|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 7.5 |
| Atrial Fibrillation | 46 Participants |
| EuroSCORE II | 7.3 Score STANDARD_DEVIATION 6.3 |
| Ischemic Etiology of Regurgitation | 37 Participants |
| Left Ventricule Ejection Fraction (LVEF) | 33 Percent Fraction STANDARD_DEVIATION 11 |
| New York Heart Association (NYHA) Functional Class III or IV | 52 Participants |
| Previous Coronary Artery Bypass Graft (CABG) | 18 Participants |
| Renal Insufficiency | 49 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 62 |
| serious Total, serious adverse events | 44 / 62 |
Outcome results
Primary
Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single | Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Death | 2 Participants |
| Single | Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Myocardial Infarction | 1 Participants |
| Single | Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Major Bleeding Complications | 2 Participants |
| Single | Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Renal Failure | 4 Participants |
| Single | Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Cardiac Tamponade | 1 Participants |
| Single | Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Respiratory Failure | 0 Participants |
Secondary
Performance [6MWT]
Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.
Time frame: Baseline, 6 and 12 months
Population: Intra-subject comparison of 18 patients who had data at all three time points (baseline, 6 and 12 months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single | Performance [6MWT] | Baseline | 334.7778 Meters | Standard Deviation 120.3957 |
| Single | Performance [6MWT] | 1 Year | 407.0556 Meters | Standard Deviation 122.8899 |
| Single | Performance [6MWT] | 6 Months | 393.2222 Meters | Standard Deviation 114.4529 |
Secondary
Performance [Full Analysis Data Set - MR Severity]
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Time frame: Baseline, discharge, 6 and 12 months
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single | Performance [Full Analysis Data Set - MR Severity] | Baseline | Moderate - Severe (3-4+) | 45 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | Baseline | Moderate (2+) | 16 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | Baseline | Trace - Mild (0-1+) | 0 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | Discharge | Moderate - Severe (3-4+) | 6 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | Discharge | Moderate (2+) | 13 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | Discharge | Trace - Mild (0-1+) | 39 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | 6 Months | Moderate - Severe (3-4+) | 3 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | 6 Months | Moderate (2+) | 11 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | 6 Months | Trace - Mild (0-1+) | 29 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | 1 Year | Moderate - Severe (3-4+) | 2 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | 1 Year | Moderate (2+) | 10 Participants |
| Single | Performance [Full Analysis Data Set - MR Severity] | 1 Year | Trace - Mild (0-1+) | 27 Participants |
Secondary
Performance [Intra-subject Comparison - MR Severity]
All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Time frame: Baseline, discharge, 6 and 12 months
Population: Intra-subject comparison of 26 patients who were assessed for MR grade across all four time points (baseline, discharge, 6 and 12 months).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Single | Performance [Intra-subject Comparison - MR Severity] | Baseline | Moderate - Severe (3-4+) | 16 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | Baseline | Moderate (2+) | 10 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | Baseline | Trace - Mild (0-1+) | 0 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | Discharge | Moderate - Severe (3-4+) | 1 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | Discharge | Moderate (2+) | 5 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | Discharge | Trace - Mild (0-1+) | 20 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | 6 Months | Moderate - Severe (3-4+) | 0 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | 6 Months | Moderate (2+) | 5 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | 6 Months | Trace - Mild (0-1+) | 21 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | 1 Year | Moderate - Severe (3-4+) | 0 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | 1 Year | Moderate (2+) | 7 Participants |
| Single | Performance [Intra-subject Comparison - MR Severity] | 1 Year | Trace - Mild (0-1+) | 19 Participants |
Secondary
Performance [MLHFQ]
Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.
Time frame: Baseline, 6 and 12 months
Population: Intra-subject comparison of 27 patients who had data at all three time points (baseline, 6 and 12 months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single | Performance [MLHFQ] | Baseline | 35.8889 Scores on a scale | Standard Deviation 16.6579 |
| Single | Performance [MLHFQ] | 6 Months | 16.2593 Scores on a scale | Standard Deviation 14.9244 |
| Single | Performance [MLHFQ] | 1 Year | 19.3333 Scores on a scale | Standard Deviation 19.9538 |
Other Pre-specified
Reduce MR [Paired Baseline and Follow-Up]
Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.
Time frame: Post-adjustment, discharge, and 30 Days
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and post-adjustment, discharge, and 30 days is 47, 50 and 46, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single | Reduce MR [Paired Baseline and Follow-Up] | Post-Adjustment | 47 Participants |
| Single | Reduce MR [Paired Baseline and Follow-Up] | Discharge | 50 Participants |
| Single | Reduce MR [Paired Baseline and Follow-Up] | 30 Days | 46 Participants |
Other Pre-specified
Technical Feasibility of Cardioband Adjustment
The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.
Time frame: Immediately after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Technical Feasibility of Cardioband Adjustment | 58 Participants |
Other Pre-specified
Technical Success Rate of the Implantation of the Cardioband
The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.
Time frame: Immediately after implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single | Technical Success Rate of the Implantation of the Cardioband | 60 Participants |