SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL AccEss


About this study

The purpose of this study is to establish the safety and effectiveness of the SAPIEN M3 System in subjects with mitral regurgitation (MR) who are at high surgical risk.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charanjit Rihal, M.D.

Open for enrollment

Contact information:

Craig Konwinski C.C.R.C.

(507) 255-8388

More information


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