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New investigational device for mitral regurgitation

Trial ID:
IRB-19-7370
Matthew J Price, M.D.
The goal of this study is to assess the safety and performance of the PASCAL System compared to the MitraClip System in patients with symptomatic, moderate to severe mitral regurgitation who may not be ideal candidates for mitral valve surgery and may be eligible for transcatheter mitral valve repair.

Inclusion Criteria

  • Be 18 years of age or older
  • Be able and willing to follow protocol procedures and comply with follow-up visit compliance
  • Have moderate to severe mitral regurgitation

Exclusion Criteria

  • Have any planned interventional cardiac procedure within 90 days of consent
  • Have any prior mitral valve surgery or transcatheter mitral valve procedure
  • Have an active infection
  • History of deep vein thrombosis (DVT) or pulmonary
  • embolism (PE)

Additional Info

  • All treatments and physician visits during this study will take place at Anderson Medical Pavilion
  • Search for NCT # 03706833 @ www.clinicaltrials.gov for more information

Contact Info:

  • Clinical Research Leadership
  • CRSLeadership@scrippshealth.org