CSTN: PRIMARY

Condition: Mitral valve regurgitation

Eligibility

Key Inclusion Criteria:

  • Adult patients ≥65 years old with moderately severe or severe primary
    degenerative mitral valve regurgitation (MR)
  • Clinical indication for mitral valve (MV) intervention and anatomic candidate for both MV transcatheter edge-to-edge and surgical repair
  • Patients across the surgical risk spectrum (low, intermediate, and high risk)

Key Exclusion Criteria:

  • Other forms of primary MR
  • Secondary or functional MR
  • Hypertrophic obstructive cardiomyopathy
Study Name

Percutaneous or Surgical Repair in Mitral Prolapse And Regurgitation for >65 Year-olds (IRB no. 0001729)

Summary

The purpose of this study is to compare the risks and benefits of two procedures used to help patients with mitral valve regurgitation (MR). MR is a condition in which the heart valve does not close fully, and blood can then leak back into the left atrium instead of circulating to the rest of the body. The study will compare transcatheter edge-to-edge repair (TEER- a catheter procedure for repairing the mitral valve that does not require surgery to open up the heart) and mitral valve repair surgery, an open-heart surgical procedure.

Both treatments are well-established and regularly performed in patients who have MR. However, the U.S. Food and Drug Administration (FDA) has not approved the investigational catheter device used in the TEER repair procedure for all types of patients with MR. Participants will be randomly assigned to receive either TEER or mitral valve repair surgery.

Principal Investigator
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