Cardiac Valve Annuloplasty, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Mitral Regurgitation, Mitral Valve Annuloplasty, Mitral Valve Insufficiency
Conditions
Keywords
Valtech Cardio, Cardioband, Mitral Valve
Brief summary
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR. Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.
Interventions
DEVICECardioband
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
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
1. Age ≥18 years 2. Severe (3+ to 4+) secondary Mitral Regurgitation 3. Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated 4. The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy. 5. Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible 6. Subject is willing and able to provide informed consent and follow protocol
Exclusion criteria
1. EF \< 20% 2. LVEDD ≥ 70 mm 3. Heavily calcified annulus or leaflets 4. Significant CAD requiring revascularization 5. Active bacterial endocarditis 6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months 7. Renal insufficiency requiring dialysis 8. Life expectancy of less than twelve months 9. Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint 10. Pulmonary hypertension ≥ 70mmHg at rest 11. Mitral valve anatomy which may preclude proper device treatment 12. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation 13. Severe liver disease 14. Patient is pregnant or lactating 15. Hypersensitivity to Nickel or Chromium 16. Clinically significant bleeding diathesis or coagulopathy 17. History of mitral valve repair 18. TIA or CVA within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale. | 30 days | Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Distance Walked on 6 Minute Walk Test | 6 months over Baseline | Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline |
| Change in Mitral Regurgitation Severity | 6, 12, and 24 months over baseline | Mitral Regurgitation at 6, 12, and 24 months compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular End Diastolic Volume (LVEDV) | 6, 12, and 24 months over baseline | Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline |
| Change in Left Ventricular End Systolic Volume (LVESV) | 6, 12, and 24 months over baselines | Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline |
| Number of Participants With Device Success | Discharge | Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge. |
| Change in Distance Walked on 6 Minute Walk Test | 12, and 24 months over baseline | Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline |
| Number of Days Alive and Out of Hospital | 12 months | Days alive and out of hospital due to major cardiovascular events at 1 year |
| Freedom From All-cause Mortality and Major Adverse Events (AE) | 30 days from implant procedure or hospital discharge, whichever is later. | Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later. |
| Need for Urgent/Emergent Surgical Intervention | 24 months | Number of patients who undergo urgent/emergent surgical intervention post procedure |
| Number of Participants With Patient Success | 6 and 12 months | Individual patient success (measured at 6 months and 1 year) defined as device success and the following: * Discharged from index hospitalization * NYHA class improvement by at least 1 level from baseline |
| Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 6, 12, and 24 months over baseline | Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. |
| Change in New York Heart Association (NYHA) Class | 6, 12, and 24 months over baseline | NYHA Class at 6, 12, and 24 months compared to baseline |
Countries
France, Germany, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardioband Patients who were enrolled and had the Cardioband procedure attempted | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Cardioband | — |
|---|---|---|
| Age, Continuous | 73.9 years STANDARD_DEVIATION 9 | — |
| Chronic Renal Disease | 8 Participants | — |
| Dilated Cardiomyopathy | 5 Participants | — |
| EuroScore II | 7.1 units on a scale STANDARD_DEVIATION 5.3 | — |
| Ischemic Etiology of Regurgitation | 4 Participants | — |
| NYHA Functional Class III or IV | 11 Participants | — |
| Paroxysmal, Persistent, Chronic Atrial Flutter/Fibrillation | 10 Participants | — |
| Previous Coronary Artery Bypass Graft | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 11 |
| other Total, other adverse events | 9 / 11 |
| serious Total, serious adverse events | 9 / 11 |
Outcome results
Primary
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Time frame: 30 days
Population: Intra-subject comparison of patients with paired data at baseline and 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioband | Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale. | 4 Participants |
Secondary
Change in Distance Walked on 6 Minute Walk Test
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Time frame: 6 months over Baseline
Population: Intra-subject comparison of patients with paired data at baseline and 6 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Cardioband | Change in Distance Walked on 6 Minute Walk Test | 30.7 Meters | Standard Deviation 60.4 |
Secondary
Change in Mitral Regurgitation Severity
Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Time frame: 6, 12, and 24 months over baseline
Population: This planned endpoint of change mitral regurgitation severity in was unable to be analyzed due to the small sample size that was achieved in this study. Data available at each time point were reported as number of patients with MR grades None/Trace, Mild, Moderate, Severe.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cardioband | Change in Mitral Regurgitation Severity | Baseline | None/Trace | 0 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | Baseline | Mild | 2 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | Baseline | Moderate | 4 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | Baseline | Severe | 3 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 6 Months | None/Trace | 1 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 6 Months | Mild | 3 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 6 Months | Moderate | 1 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 6 Months | Severe | 0 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 12 Months | None/Trace | 0 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 12 Months | Mild | 3 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 12 Months | Moderate | 0 Participants |
| Cardioband | Change in Mitral Regurgitation Severity | 12 Months | Severe | 0 Participants |
Other Pre-specified
Change in Distance Walked on 6 Minute Walk Test
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline
Time frame: 12, and 24 months over baseline
Population: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Other Pre-specified
Change in Left Ventricular End Diastolic Volume (LVEDV)
Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time frame: 6, 12, and 24 months over baseline
Population: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Other Pre-specified
Change in Left Ventricular End Systolic Volume (LVESV)
Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time frame: 6, 12, and 24 months over baselines
Population: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Other Pre-specified
Change in New York Heart Association (NYHA) Class
NYHA Class at 6, 12, and 24 months compared to baseline
Time frame: 6, 12, and 24 months over baseline
Population: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Other Pre-specified
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
Time frame: 6, 12, and 24 months over baseline
Population: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Other Pre-specified
Freedom From All-cause Mortality and Major Adverse Events (AE)
Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.
Time frame: 30 days from implant procedure or hospital discharge, whichever is later.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioband | Freedom From All-cause Mortality and Major Adverse Events (AE) | 10 Participants |
Other Pre-specified
Need for Urgent/Emergent Surgical Intervention
Number of patients who undergo urgent/emergent surgical intervention post procedure
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioband | Need for Urgent/Emergent Surgical Intervention | 0 Participants |
Other Pre-specified
Number of Days Alive and Out of Hospital
Days alive and out of hospital due to major cardiovascular events at 1 year
Time frame: 12 months
Population: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Other Pre-specified
Number of Participants With Device Success
Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.
Time frame: Discharge
Population: The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioband | Number of Participants With Device Success | 7 Participants |
Other Pre-specified
Number of Participants With Patient Success
Individual patient success (measured at 6 months and 1 year) defined as device success and the following: * Discharged from index hospitalization * NYHA class improvement by at least 1 level from baseline
Time frame: 6 and 12 months
Population: The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cardioband | Number of Participants With Patient Success | 6 Months | 3 Participants |
| Cardioband | Number of Participants With Patient Success | 12 Months | 3 Participants |