Status:
COMPLETED
MitraClip Russia Trial
Lead Sponsor:
Abbott Medical Devices
Conditions:
Functional Mitral Regurgitation
Degenerrative Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a ...
Detailed Description
Mitral regurgitation (MR) is the most common heart valve condition in the world. MR occurs when the mitral valve does not close properly, allowing blood to leak back into the upper chamber of the hear...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic DMR or FMR determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days or transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration.
- LVEF ≥ 30%
- NYHA classification is class II, class III, or ambulatory class IV.
- Subject is deemed difficult for mitral valve surgery due to either STS surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors (Porcelain aorta or mobile ascending aortic atheroma, Post-radiation mediastinum, Previous mediastinitis, Functional MR with LVEF\<40%, Over 75 years old with LVEF\<40%, Re-operation with patent grafts, Two or more prior cardiothoracic surgeries, Hepatic cirrhosis, Other surgical risk factor(s))
- Mitral valve area ≥ 4.0 cm2.
- The primary regurgitant jet is non-commisural, and in the opinion of the implanting investigator can successfully be treated by the MitraClip NT System. If a secondary jet exists, it must be considered clinically insignificant
Exclusion
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow up period
- Patients with the following conditions: Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.
- Contraindications for reusable accessories (stabilizer, lift, support plate)
- 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
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04350372
Start Date
February 18 2020
End Date
October 2 2020
Last Update
June 14 2022
Active Locations (1)
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1
FSBI "NICC of Cardiology" of the Ministry
Moscow, Russia