Clinical Trials

Inclusion Criteria:

• 18 years of age or older.
• MR ≥ 3+ as assessed by the Echo Core Lab (See MAC Registry).
• NYHA functional class ≥ II.
• Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
• 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.
  • Note: Subjects who require significant changes to heart failure medication after enrollment but prior to the procedure must re-stabilize for 30 days to be eligible.
• 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:

• Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the dock or valve, including but not limited to:
  • Annular dimensions that could potentially increase the risk of paravalvular leak (as assessed by Computed Tomography [CT] core lab);
  • Commissural jet or lateral commissural flail/prolapse that could potentially increase the risk of paravalvular leak;
  • Medial commissural flail or prolapse;
  • Calcification that would interfere with the SAPIEN M3 System during delivery or after implantation; if potential for interference is uncertain, see MAC Registry;
  • Interatrial septum or left atrium not suitable for transcatheter trans-septal access;
  • LVEDD ≥ 75 mm as assessed by Echo core lab;
  • Sub-valvular anatomy that is unsuitable for dock encircling as assessed by CT core lab;
  • Significant risk of LVOT obstruction as assessed by CT core lab.
• Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 Dock and Valve
• Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation.
• LVEF < 25% as assessed by Echo core lab.
• Severe right ventricular dysfunction as assessed by Echo core lab.
• Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months.
• History of heart transplant.
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
• Active bacterial endocarditis within 180 days of the procedure.
• Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure.
• Myocardial infarction within 30 days of the procedure.
• Clinically significant untreated coronary artery disease requiring revascularization.
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure; TEER procedures are excluded regardless of timeframe (See Failed TEER Registry).
• Stroke or transient ischemic attack within 90 days of the procedure.
• Irreversible, severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 2/3 systemic pressure).
• Chronic obstructive pulmonary disease (COPD) requiring home oxygen therapy or chronic outpatient oral steroid use.
• Renal insufficiency (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2 ) or receiving renal replacement therapy.
• Liver disease (cirrhosis of the liver [Child-Pugh class B or C]).
• Planned surgery within the next 12 months.
• Inability to tolerate or a medical condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy, including heparin administration during the procedure.
• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics).
• Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments (as assessed by the Case Review Board).
• Leukopenia (White Blood Cells < 3000 cells/mL), anemia (Hemoglobin < 9 g/dL), thrombocytopenia (platelet < 50,000 cells/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Refusal of blood products.
• Female who is pregnant or lactating.
• Estimated life expectancy < 12 months due to non-cardiac conditions.
• Participating in another investigational drug or device study that has not reached its primary endpoint.
• Subject considered to be part of a vulnerable population.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/2/22. Questions regarding updates should be directed to the study team contact.