MitraClip REPAIR MR Study

Launched by ABBOTT MEDICAL DEVICES · Dec 12, 2019

Keywords

ClinConnect Summary

The MitraClip REPAIR MR Study is a clinical trial designed to compare two treatment options for patients with severe mitral valve regurgitation (a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward). The study will look at the effectiveness of the MitraClip™ device, which is a less invasive procedure, versus traditional surgical repair of the mitral valve. This trial is specifically for patients who are at moderate risk for surgery and have been evaluated by a team of heart doctors to ensure their mitral valve can be safely treated.

To qualify for the study, participants should be at least 18 years old and have severe mitral valve regurgitation confirmed by a doctor. They should also be experiencing symptoms or have specific heart function issues. Participants will need to provide consent to join the study and will be carefully monitored throughout the trial. If you or a loved one is facing this heart condition and meets the eligibility criteria, this study may offer a chance to receive cutting-edge treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

• 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