Mitral Valve Regurgitation
Conditions
Keywords
MitraClip
Brief summary
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Interventions
DEVICEMitraClip™ device implantation
Transcatheter repair of the mitral valve using MitraClip™ device
PROCEDUREMitral Valve Repair Surgery
Surgical repair of the mitral valve
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL. 2. The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild 3. Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure \> 50 mmHg, or LVESD \> 40 mm 4. Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have: 1. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR 2. Presence of other comorbidities which may introduce a potential surgery-specific impediment 5. Subject provides written informed consent 6. Subject is ≥ 18 years of age
Exclusion criteria
1. Subject is currently participating in another clinical investigation 2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 3. Subject has ischemic or non-ischemic secondary MR 4. Concomitant severe tricuspid valve regurgitation 5. Ejection fraction \<30% 6. Severe mitral annular calcification 7. Acute myocardial infarction in the past 12 weeks 8. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease 9. Subjects who have concurrent coronary artery disease that needs to be treated may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip™ device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery 10. Surgical procedure performed in the past 30 days 11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT 12. Transesophageal echocardiography (TEE) is contraindicated. 13. Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP 14. Need for emergency surgery for any reason 15. Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD 16. Systolic anterior motion of the mitral valve 17. Hypertrophic cardiomyopathy 18. Renal insufficiency requiring dialysis 19. Active infections requiring current antibiotic therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded) | 2 Years | The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively |
| Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) | 2 Years | Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors | 30 Days | The proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors will be compared between the Device and Control groups |
| Number of days at hospital from index procedure to home discharge | At Discharge (≤ 14 days following index procedure) | Hospital length of stay from index procedure to home discharge (days) in Device group compared to the Control group |
| Proportion of subjects discharged to home post index hospitalization | At Discharge (≤ 14 days following index procedure) | The proportion of subjects who are discharged to home post index hospitalization will be compared between the Device and Control groups |
| Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors. | 2 Years | The proportion of subjects who have at least a 10 point improvement in KCCQ at 2 years post index procedure from baseline among survivors will be compared between the Device and Control groups for non-inferiority. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered questionnaire used for quantifying patient's health status including the symptoms (frequency and burden), physical and social limitations, and quality of life impact due to the heart failure syndrome. Validity, reproducibility, responsiveness and interpretability of the scores have been independently established for each of these health status domains, and overall summary scores are reported in a range of 0-100, in which higher scores reflect better health status. |
| Severe symptomatic mitral stenosis at 1 year | 1 Year | The proportion of subjects who have severe symptomatic mitral stenosis at 1 year post index procedure will be compared between the Device and Control groups |
Countries
Canada, Germany, Switzerland, United States
Contacts
PRINCIPAL_INVESTIGATORPatrick McCarthy, MD
Northwestern Memorial Hospital
PRINCIPAL_INVESTIGATORSaibal Kar, MD
Los Robles Regional Medical Center
Outcome results
None listed