AI-Powered Research

General
1. * 65 years old.
2. Willing and able to comply with all required follow-up evaluations and assessments.
3. Subject or authorized representative has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study.
Heart Failure Status
4. New York Heart Associate Classification * III
5. Left Ventricular Ejection Fraction * 30%.
6. Mitral regurgitation (MR) * Grade 3+ (moderate/severe, or severe) using the AHA/ACC 2014 Guidelines for the Management of Patients with Valvular Heart Disease (as published in Circulation March 3, 2014).
7. STS mortality score * 8% or determined to be high or extreme surgical risk by a Cardiac Surgeon.
8. Hemodynamically stable while on heart failure medication for at least 30 days before the procedure.
Anatomical
9. Left atrial height * 4 cm.
10. Left Ventricular End Systolic Diameter (LVESD) * 6 cm.
11. Mitral valve major (single axis) annulus diameter meets the range of 36-39.5 mm.
12. Angle of mitral valve axis to aortic valve axis is deemed unlikely to be obstructive by the Investigator.
13. Suitable left ventricular anatomy for delivery system access per the medical opinion of the Investigator.

Exclusion Criteria

General
1. Currently participating in another investigational drug or device study.
2. Need for emergent or urgent surgery for any reason.
3. Any condition that, in the opinion of the Investigator, could interfere with Subject participation, confound the study results or interfere with study compliance.
Anatomical
4. Lack of chordal support of the mitral valve (i.e., ruptured papillary muscle or secondary chords).
5. Severe calcification of any component of the mitral valve, including one or both of the mitral leaflets.
6. Myocardial infarction within the previous 6 weeks.
7. Intra-cardiac thrombus, mass or vegetation.
8. Need for native aortic or pulmonic valve replacement.
Existing Co-morbidities
9. Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve.
10. Pre-existing mechanical prosthetic valve in the aortic position.
11. History of cardiac transplantation.
12. Any history of pulmonary embolism.
13. Clinically significant, untreated coronary artery disease.
14. Percutaneous coronary intervention within the prior 30 days.
15. Contraindication to Transesophageal/Transoesophageal Echocardiography (TEE/TOE).
16. Active endocarditis or rheumatic heart disease within the previous 3 months.
17. Refractory, unstable angina.
18. Significant cerebral vascular event within the previous 3 months.
19. Atrial fibrillation with uncontrolled heart rate (> 100 bpm).
20. Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction, cardiogenic shock or the need for inotropic or intra-aortic balloon pump support).
21. Untreatable hypersensitivity or contraindication to any of the following:
* Aspirin and Clopidogrel and Ticlopidine, OR
* Heparin and Bivalirudin, OR
* Warfarin, Nitinol Alloys (nickel and titanium), contrast media, glutaraldehyde or bovine tissue.
22. Bleeding diathesis or coagulopathy, or Subject refuses blood transfusion.
23. Active peptic ulcer or GI bleeding.
24. Severe pulmonary hypertension (> 55 mmHg) and severe COPD (FEV1/FVC < 70% and FEV1 < 50% predicted FEV1).
25. Severe right ventricular systolic dysfunction.
26. Severe tricuspid valve regurgitation (Grade 4+)
27. Pulmonary function FEV1 (< 750 cc).
28. Subject has severe kidney disease with
* Creatinine level > 194 µmol/L (2.2 mg/dL) OR
* eGFR * 30 mL/min.
29. Liver disease, cirrhosis of the liver or significantly abnormal liver function test results.
30. Significant uncorrected endocrinology deficiency.
31. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months.
32. Active infections that requires antibiotic therapy (if temporary illness, Subjects may enroll 2 weeks after discontinuation of antibiotics). Subjects must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the percentage of Subjects with a composite Major<br /><br>Adverse Event (MAE) at 30 days for the following events: cardiovascular<br /><br>mortality, myocardial infarction, disabling stroke and conversion to surgery<br /><br>per VARC definitions.</p><br>

Secondary Outcome Measures