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Investigational device for Heart Failure

Trial ID:
IRB-18-7272
Matthew J Price, M.D.
The purpose of this study is to evaluate the safety and effectiveness of an investigational shunt to treat symptomatic heart failure.

Inclusion Criteria

Patients must:
  • Be 18 years of age or older
  • Have ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fractions and documented heart failure for at least 6 months
  • Be on stable heart failure medications for at least 1 month, with exception of diuretic therapy
  • Be willing and able to comply with required tests, treatment instructions and follow-up visits

Exclusion Criteria

Patients must not:
  • Require surgical or percutaneous cardiac intervention
  • Have an active infection
  • Be allergic to nickel

Additional Info

  • All treatments and physician visits during this study will take place at Anderson Medical Pavilion and Scripps Memorial Hospital Lab Jolla.
  • Patients will be randomized to receive the investigational shunt device or usual care. The shunt is placed during a minimally invasive cardiac catheterization procedure using a dedicated delivery catheter.
  • The goal of the study is to see if the shunt improves symptoms of heart failure.
  • For more information search NCT# 03499236 on the Clinical Trials website at www.clinicaltrials.gov

Contact Info:

  • Clinical Research Leadership
  • CRSLeadership@scrippshealth.org