Summary

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Age: 18 Years and older

Gender: All

Start Date: 11/12/2020

Primary Completion Date (Estimated): 02/28/2027

Study Completion Date (Estimated): 02/28/2031

Accepts Healthy Volunteers: No

Trial Purpose and Description

This is a prospective single-arm, multicenter study.

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

1. 18 years of age or older

2. MR ≥ 3+

3. NYHA functional class ≥ II

4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.

5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.

6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria:

1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve

2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve

3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation

4. Left ventricular ejection fraction \<25%

5. Severe right ventricular dysfunction

6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months

7. History of heart transplant

8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

9. Active bacterial endocarditis within 180 days of the procedure

10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure

11. Myocardial infarction within 30 days of the procedure

12. Clinically significant untreated coronary artery disease requiring revascularization

13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure

14. Stroke or transient ischemic attack within 90 days of the procedure

15. Irreversible, severe pulmonary hypertension

16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use

17. Renal insufficiency or receiving renal replacement therapy

18. Liver disease

19. Planned surgery within the next 12 months

20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure

21. Active infection requiring current antibiotic therapy

22. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states

24. Refusal of blood products

25. Female who is pregnant or lactating

26. Estimated life expectancy \<12 months due to non-cardiac conditions

27. Participating in another investigational drug or device study that has not reached its primary endpoint

28. Subject considered to be part of a vulnerable population