A Study to Evaluate Mitral Implantation of Transcatheter Valves


About this study

The purpose of this study is to enroll high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.

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.
  • Severe mitral annular calcification with severe mitral stenosis defined as mitral valve area (MVA) of ≤ 1.5 cm^2, or moderate to severe or severe mitral regurgitation.
  • NYHA Functional Class ≥ II.
  • The heart team agrees that valve implantation will likely benefit the patient.
  • High or prohibitive risk for standard mitral valve surgery as determined by the heart team (at least one site cardiac surgeon must personally examine the subject to determine operative risk).
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  • The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.

Exclusion Criteria:

  • The heart team considers the patient is a surgical candidate.
  • Mitral annulus is not calcified.
  • Myocardial infarction requiring revascularization within 30 days from procedure.
  • Clinically significant untreated coronary artery disease requiring revascularization.
  • Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not excluded.
  • Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to procedure after a qualifying Echo).
  • Severe tricuspid regurgitation requiring surgery.
  • Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL), history of coagulopathy or hypercoagulable state.
  • Hypertrophic obstructive cardiomyopathy (HOCM) with mean LVOT gradient of ≥ 20 mm Hg at rest or ≥ 50 mmHg with Valsalva.
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
  • Need for emergency surgery for any reason.
  • Severe left ventricular dysfunction with LVEF < 20%.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Active upper GI bleeding within 90 days prior to procedure.
  • A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
  • Cardiac anatomy that would preclude appropriate delivery and deployment of a SAPIEN 3 or SAPIEN 3 Ultra valve in MAC via transseptal access, including but not limited to:
    • Native neo mitral annulus size < 275 mm^2 or > 810 mm^2 as measured by CT scan;
    • Significant risk of LVOT obstruction or valve embolization as assessed by CT core lab.
  • Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 90 days of the procedure.
  • Estimated life expectancy < 12 months due to non-cardiac conditions.
  • Expectation that patient will not improve despite treatment of mitral valve dysfunction.
  • Active bacterial endocarditis within 180 days of procedure.
  • Severe right ventricular dysfunction as assessed by Echo core lab 22.
  • Active infection requiring antibiotic therapy (subject may be a candidate after 2 weeks of antibiotic discontinuation.
  • Female who is pregnant or lactating.
  • Participating in another investigational device study.
  • Aortic valve disease requiring intervention.
  • Severe fixed pulmonary hypertension (PASP ≥ 70 mmHg).
  • Severe chronic obstructive pulmonary disease requiring continuous home oxygen.

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

Mackram Eleid, M.D.

Open for enrollment

Contact information:

Rachel Love

(507) 293-3929


More information


  • Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. Read More on PubMed
  • To evaluate the outcomes of the early experience of percutaneous alcohol septal ablation in patients with severe left ventricular outflow tract (LVOT) obstruction post transcatheter mitral valve replacement (TMVR). Read More on PubMed
  • Transcatheter implantation of balloon expandable valves in native mitral valves (MV) has been performed in patients with severe MV annular calcification who are not good candidates for standard surgical MV replacement. Significant left ventricular outflow tract (LVOT) obstruction with hemodynamic compromise has been described as one of the potential complications of transcatheter MV replacement. Surgical rescue carries significant risk in this high-risk patient population. We describe a percutaneous technique to acutely decrease transcatheter MV replacement-induced LVOT obstruction. © 2016 Wiley Periodicals, Inc. Read More on PubMed
  • Patients with mitral annular calcification (MAC) have high surgical risk for mitral valve replacement due to associated comorbidities and technical challenges related to calcium burden, precluding surgery in many patients. Transcatheter mitral valve replacement (TMVR) with the compassionate use of balloon expandable aortic transcatheter heart valves has been used in this clinical scenario. The purpose of this review was to summarize the early experience including successes and failures reported. TMVR might evolve into an acceptable alternative for selected patients with severe MAC who are not candidates for conventional mitral valve surgery. However, this field is at a very early stage and the progress will be significantly slower than the development of transcatheter aortic valve replacement due to the complexity of the mitral valve anatomy and its pathology. Optimizing patient selection process by using multimodality imaging tools to accurately measure the mitral valve annulus and evaluate the risk of left ventricular outflow tract obstruction is essential to minimize complications. Strategies for treating and preventing left ventricular outflow tract obstruction are being tested. Similarly, carefully selecting candidates avoiding patients at the end of their disease process, might improve the overall outcomes. Read More on PubMed
  • Transcatheter implantation of a balloon expandable valve in calcified severely stenosed native mitral valves has recently been described. The two cases reported so far utilized the surgical transapical approach generally used for transapical transcatheter aortic valve replacement. A percutaneous approach has not been published. We report the first successful percutaneous implantation of a balloon expandable transcatheter valve in the native mitral valve without a surgical incision. Read More on PubMed

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