MitraClip Russia Trial
MitraClip Russia Trial
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 viable therapeutic option for patients at high risk for open-heart
 surgery. Treatment with the MitraClip device allows patients to undergo a less invasive
 procedure that can mechanistically reduce MR and allow for improved quality of life. The
 MitraClip procedure is performed under general anesthesia without the use of a heart-lung
 machine, with recovery typically lasting two to three days.

 The objective of this study is to evaluate safety and effectiveness of the MitraClip NT
 procedure in the Russian population for treatment of Mitral Regurgitation.
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 heart. As a result, the heart may try to pump harder in order to compensate
 for the decrease in blood flow to the rest of the body. Patients with severe MR suffer from
 debilitating symptoms such as shortness of breath, heart palpitations, lightheadedness, and
 fatigue. These patients are at risk of poor quality of life, marked limitation in activity,
 repeated heart failure hospitalizations, and increased mortality. Chronic severe MR is often
 associated with heart failure and can lead to death if left untreated.

 While mitral valve repair or replacement surgery is currently regarded as standard of care,
 many patients with clinically significant MR are at an unacceptable risk of morbidity and
 mortality and are therefore not appropriate surgical candidates. To optimize afterload
 reduction and treatment of fluid load, these patients are often treated with medical
 management (i.e., beta blockers, ACE inhibitors, angiotensin II receptor blockers) which may
 relieve MR symptoms, but does not address the underlying cause of the condition. As a result,
 a significant portion of patients treated medically continue to progress to heart failure and
 experience an increasingly debilitating quality of life. A significant unmet clinical need
 thus exists for the treatment of moderate-to-severe and severe MR in high surgical risk
 patients.

 The MitraClip System has been in clinical use for treatment of significant MR since 2003. The
 device received CE (Conformité Européenne) Mark for both DMR and FMR indications in March
 2008 and was approved by FDA for DMR indication in October 2013 and for FMR indication in
 March 2019. The system is approved for use in more than 80 countries or regions. More than
 80,000 patients have undergone the MitraClip procedure worldwide, with the majority of
 experience in high surgical risk patients.
Inclusion Criteria:

 -  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 Criteria:

 -  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