MitraClip REPAIR MR Study
Purpose
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.
Condition
- Mitral Valve Regurgitation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Control Arm |
Mitral Valve Repair Surgery |
|
|
Experimental Device Arm |
MitraClip™ device implantation |
|
Recruiting Locations
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices