The ENCIRCLE Trial

This is a prospective single-arm, multicenter study.

Inclusion criteria

• 18 years of age or older
• MR ≥ 3+
• 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.
• 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 SAPIEN M3 dock or valve
• 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
• Left ventricular ejection fraction <25%
• Severe right ventricular dysfunction
• 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
• Stroke or transient ischemic attack within 90 days of the procedure
• Irreversible, severe pulmonary hypertension
• Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
• Renal insufficiency or receiving renal replacement therapy
• Liver disease
• Planned surgery within the next 12 months
• Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
• Active infection requiring current antibiotic therapy
• Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
• Leukopenia, anemia, thrombocytopenia, 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