Overview

The objective of this clinical trial is to evaluate the safety and effectiveness of the Cephea Mitral Valve System in subjects with symptomatic mitral valve disease (MVD) or are deemed unsuitable for surgery and transcatheter repair.

Eligibility

Inclusion Criteria:

1. Mitral valve dysfunction meeting one of the following severity criteria:
   1. Mitral Annular Calcification (MAC) associated with at least one of the following: i. Grade III or higher mitral regurgitation (MR) ii. Severe mitral stenosis (MS) iii. Concomitant moderate (Grade II) MR and moderate MS b. Grade III or higher MR of primary or secondary etiology
2. The subject is deemed unsuitable for both conventional mitral valve surgery and transcatheter mitral valve repair
3. NYHA functional class II or higher
4. Left Ventricular Ejection Fraction of at least 25%
5. Left Ventricular End Diastolic Dimension ≤ 75mm
6. The Site Heart Team determines that the subject has been adequately treated per applicable standards for coronary artery disease, left ventricular dysfunction, cardiac arrhythmias, and heart failure
7. 18 years of age or older
8. The subject agrees to the study requirements and has provided written informed consent

Exclusion Criteria:

1. Currently participating in another investigational drug or device study that has not reached its primary endpoint.
2. 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 safety or ability to participate in the clinical investigation or to comply with the follow-up requirements, or impact the scientific soundness of the clinical investigation results.
3. Prior surgical or interventional treatment that can interfere with the Cephea Valve delivery or function
4. Iliofemoral venous anatomy that is insufficient for the introduction and delivery of the Cephea Valve or Delivery System
5. Any planned cardiac surgery or intervention within the next 12 months
6. Any planned surgery in the next 12 months that is expected to adversely impact mobility or the subject's quality of life
7. Imaging evidence of intracardiac mass, vegetation, or thrombus at risk of embolization
8. Moderate or severe aortic stenosis, or aortic valve disease requiring surgery or transcatheter intervention
9. Severe tricuspid or pulmonary valvular regurgitation, or valve disease requiring surgery or transcatheter intervention
10. Evidence of right-sided congestive heart failure or severe right ventricular dysfunction
11. Subject is undergoing dialysis or has chronic renal failure
12. Subject has fixed pulmonary arterial hypertension
13. Moderate to severe liver disease
14. Prior orthotopic heart transplantation
15. Unresolved severe carotid stenosis, or symptomatic carotid stenosis of any severity
16. Hypertrophic or restrictive cardiomyopathy, or constrictive pericarditis that would interfere with Cephea Valve fit or function
17. Known hypersensitivity or contraindication to procedural or post-procedural medications that cannot be adequately managed
18. Known hypersensitivity to nickel or titanium that cannot be appropriately managed
19. Transesophageal echocardiography (TEE) is contraindicated or high risk
20. Chronic lung disease requiring continuous home oxygen therapy
21. Modified Rankin Scale ≥ 4 disability
22. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period