MitraClip Russia Trial

Study Overview
=================
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 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.

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 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.

Official Title
-----------------
The MitraClip Russia Trial: A Prospective, Single-Center, Single-Arm Clinical Evaluation of the MitraClip System for the Treatment of Mitral Regurgitation

Conditions
-----------------
Functional Mitral Regurgitation, Degenerrative Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: MitraClip Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MitraClip<br>Subject will receive MitraClip procedure with MitraClip NT System | Device: MitraClip Procedure<br>* MitraClip procedure with MitraClip NT System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Successful Implantation of the MitraClip NT Device | Successful implantation of the MitraClip NT device resulting in a decrease in the MR severity grade as assessed from the discharge echocardiogram (10-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge will be considered a failure for the procedure | 30-day |