Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Mitral Regurgitation
• Age: Between 21 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Moderately severe or severe mitral regurgitation (MR Grade = 3+)
  2. Symptomatic mitral regurgitation (NYHA Class II-IV)
  3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not optimal for commercially approved transcatheter mitral valve therapies
  4. Native mitral valve geometry and size compatible with the Half Moon TMVr implant
  5. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
  6. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits

  
  

You may not be eligible for this study if the following are true:

• 1. Prior transseptal intervention with occlusion device currently implanted
  2. Implanted with venous stents (iliac and femoral)
  3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
  4. Prohibitive mitral annular or leaflet calcification, or anterior leaflet flail or prolapse
  5. Left ventricular ejection fraction (LVEF) < 25%, or LVEF 25-30%
  6. Left ventricular end diastolic diameter (LVEDD) > 75mm
  7. Pulmonary hypertension
  8. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
  9. Severe tricuspid regurgitation
  10. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure
  11. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
  12. Prior stroke, TIA, or myocardial infarction within 90 days
  13. Need for coronary revascularization
  14. Severe symptomatic carotid artery stenosis
  15. Severe Chronic Obstructive Pulmonary Disease (COPD)
  16. Need for emergent surgery
  17. Endocarditis within 6 months
  18. Participants unwilling or unable to adhere to the protocol recommended anticoagulation treatment
  19. GI bleeding within 6 months
  20. History of bleeding diathesis or coagulopathy or participant will refuse blood transfusion
  21. Hemodynamic instability
  22. Renal insufficiency
  23. Active infections requiring current antibiotic therapy
  24. Contraindication to transesophageal echocardiography (TEE)
  25. Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically
  26. Pregnant, nursing or planning to be pregnant
  27. Currently participating in an investigational drug or another device study