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MitraClip device for patients at moderate risk for surgery

Trial ID:
IRB-20-7647
Matthew J Price, M.D.
The purpose of this research is to extend the current approved indication of the MitraClip device to include patients who are considered moderate-risk candidates for traditional mitral valve repair surgery.

Inclusion Criteria

Patients must:
  • Must be 18 years old or older
  • Must be at moderate surgical risk for mitral valve repair
  • Must have severe mitral regurgitation
  • Be willing to participate in the trial for 10 years

Exclusion Criteria

Patients must not:
  • Be currently participating in another clinical trial
  • Have secondary mitral regurgitation
  • Have severe tricuspid regurgitation or severe valve disease
  • Have had a heart attack in the last year

Additional Info

  • The MitraClip device is currently approved by the FDA for patients who are at high-risk for traditional surgery, but is not approved for patients considered moderate to low surgical risk.
  • All treatments and physician visits during this study will take place at Anderson Medical Pavilion, Scripps La Jolla. Study participation will last up to 10 years

Contact Info:

  • Clinical Research Services
  • gil-flamer.john@scrippshealth.org