The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). (MITRAL-II)

This is an interventional treatment trial for Mitral Annular Calcification focused on measuring Transcatheter Mitral Valve Replacement Read More

Inclusion Criteria:

All Candidates must meet the following criteria:

1. - 18 years of age or older
2. -Severe mitral annular calcification with severe mitral stenosis defined as mitral valve area (MVA) of ≤1.5 cm2, or moderate to severe or severe mitral regurgitation.
3. - NYHA Functional Class ≥II.
4. The heart team agrees that valve implantation will likely benefit the patient.
5. High or prohibitive risk for standard mitral valve surgery as determined by the heart team (at least one site cardiac surgeon must personally examine the subject to determine operative risk).
6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
7. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.

Exclusion Criteria:

1. - The heart team considers the patient is a surgical candidate.
2. - Mitral annulus is not calcified.
3. - Myocardial infarction requiring revascularization within 30 days from procedure.
4. - Clinically significant untreated coronary artery disease requiring revascularization.
5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not excluded.
6. Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to procedure after a qualifying Echo).
7. Severe symptomatic tricuspid regurgitation (hepatic dysfunction, ascites, edema not controlled with diuretics) requiring surgery.
8. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Platelets < 50,000 cell/mL), history of coagulopathy or hypercoagulable state.
9. Hypertrophic obstructive cardiomyopathy (HOCM) with mean LVOT gradient of ≥20 mm Hg at rest or ≥50 mmHg with Valsalva.
10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
11. Need for emergency surgery for any reason.
12. Severe left ventricular dysfunction with LVEF < 20%.
13. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
14. Active upper GI bleeding within 90 days prior to procedure.
15. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.

16. Cardiac anatomy that would preclude appropriate delivery and deployment of a SAPIEN 3 or SAPIEN 3 Ultra valve in MAC via transseptal access, including but not limited to:

    • Native neo mitral annulus size < 275 mm2 or > 810 mm2 as measured by CT scan.
    • Significant risk of LVOT obstruction or valve embolization as assessed by CT core lab
17. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 90 days of the procedure.
18. Estimated life expectancy <12 months due to non-cardiac conditions.
19. Expectation that patient will not improve despite treatment of mitral valve dysfunction.
20. Active bacterial endocarditis within 180 days of procedure.
21. - Severe right ventricular dysfunction as assessed by Echo core lab
22. - Active infection requiring antibiotic therapy (subject may be a candidate after 2 weeks of antibiotic discontinuation.
23. - Female who is pregnant or lactating.
24. - Participating in another investigational device study.
25. - Aortic valve disease requiring intervention.
26. - Severe fixed pulmonary hypertension (PASP ≥70 mmHg).
27. - Severe chronic obstructive pulmonary disease requiring continuous home oxygen.
28. - The patient refuses mitral valve intervention
29. - Recent symptomatic COVID-19 infection with residual symptoms that may affect the outcomes of this trial.