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Evaluating the SAPIEN M3 System for treating severe mitral regurgitation

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

Not applicable Interventional Edwards Lifesciences · NCT04153292

This study is testing a new device called the SAPIEN M3 System to see if it can safely help people with severe mitral regurgitation who can't have other treatments.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment900 (estimated)
Ages18 Years and up
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations68 sites (Huntsville, Alabama and 67 other locations)
Trial IDNCT04153292 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the SAPIEN M3 System in patients suffering from symptomatic mitral regurgitation (MR) rated at least 3+, who are not suitable candidates for existing surgical or transcatheter treatments. It is a prospective, single-arm, multicenter study that will enroll participants and monitor their outcomes following the intervention. The study will also include a continued access phase for participants after enrollment is completed.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic mitral regurgitation of at least 3+ who are deemed unsuitable for other treatment options.

Not a fit: Patients with anatomical issues that prevent the delivery of the SAPIEN M3 System or those with severely reduced left ventricular ejection fraction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with severe mitral regurgitation who currently have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar transcatheter approaches for mitral valve treatment, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Huntsville, Alabama and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral RegurgitationMitral Valve Insufficiency
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.