Early Feasibility Study of the Capstan Medical TMVR System

Inclusion Criteria:

1. Age ≥ 18 years at the time of consent.
2. Moderate-to-severe or severe mitral regurgitation.
3. NYHA II or greater symptoms.
4. The participant is considered to be at elevated, but not prohibitive, surgical risk for mitral valve replacement, as determined by the local multi-disciplinary heart team and/or a validated surgical risk assessment tool (e.g., STS PROM).
5. The local multi-disciplinary heart team determines that surgical mitral valve replacement is not the preferred treatment option and that the participant is an appropriate candidate for treatment with the Capstan System.
6. The local multi-disciplinary heart team determines that the participant is unsuitable for mitral transcatheter edge-to-edge repair (mTEER) due to anatomical, technical, and/or clinical reasons.
7. The local multi-disciplinary heart team deems heart failure management is optimized based on participant characteristics and applicable guidelines.
8. Ability and willingness to provide written informed consent prior to any study related procedure(s)

Exclusion Criteria:

1. LVEF \< 25%
2. Anatomic features unsuitable for the Capstan System.
3. Inappropriate anatomy for femoral venous introduction and delivery of the Capstan System.
4. Severe mitral stenosis.
5. Untreated severe aortic or pulmonic valve disease (stenosis or regurgitation).
6. Untreatable severe right ventricular dysfunction or severe tricuspid valve disease.
7. Evidence of intracardiac thrombus, vegetation, or mass.
8. Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve.
9. Any cardiac or vascular procedure performed within 30 days prior to procedure.
10. Myocardial infarction within 30 days prior to enrollment.
11. Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure.
12. Active endocarditis, other ongoing infection requiring antibiotic therapy.
13. Stroke or transient ischemic attack (TIA) within 30 days of procedure.
14. Active peptic ulcer or active gastrointestinal bleeding.
15. PASP \> 70mmHg or PVR \> 5 Wood units after vasodilator challenge.
16. End-stage renal failure on dialysis or eGFR ≤ 25.
17. Concurrent medical condition with a life expectancy of less than 12 months.
18. Participant is on the waiting list for a heart transplant or has had a prior heart transplant.
19. Pregnant (participants of childbearing age are required to have a negative pregnancy test).
20. Known allergy or hypersensitivity to device materials (e.g. nitinol, PET), or a documented allergy to heparin, that cannot be adequately medicated; a history of HIT, or contraindication to required antithrombotic therapies.
21. Contraindication to or inability to tolerate the protocol-required therapeutic anticoagulation regimen for the 6-months post-procedure period.
22. Participant is contraindicated for transesophageal echocardiography (TEE).
23. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
24. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure.
25. Clinically significant untreated coronary artery disease requiring revascularization.
26. Chronic Obstructive Pulmonary Disease (COPD) on continuous O2 therapy.
27. Refusal of blood products.
28. Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
29. Planned cardiac intervention in the next 12 months.