The purpose of this study is to evaluate the safety and effectiveness of an investigational shunt to treat symptomatic heart failure.
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
Patients must not:
Require surgical or percutaneous cardiac intervention
Have an active infection
Be allergic to nickel
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