Device for Heart failure patients with preserved Ejection fraction

Trial ID:
IRB-17-7009
Rajeev Mohan, MD
This study will test the safety and effectiveness of the Corvia Medical atrial shunt. Patients will be followed for at least 5 years after the device is implanted, and follow-ups will occur about every 6 months.

Inclusion Criteria

  • Have a diagnosis of Heart failure
  • Have been treated with diuretics for at least 30 days
  • Have ejection Fraction of over 40%
  • Be over 40 years old
  • Meet all other eligibility criteria

Exclusion Criteria

  • Have had a major heart procedure in last 3- 12 months
  • Be unable to walk
  • Be on the cardiac transplant waiting list
  • Have had a stroke, transient ischemic attack, deep vein thrombosis, or pulmonary emboli within the past 6 months
  • Meet any other exclusion criteria

Additional Info

  • The Corvia shunt is designed to be permanently implanted in the atrial septum to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
  • Patients will be randomized, like the flip of a coin, to get the Corvia device or a sham (no device) procedure. Patients that are randomized to the “sham” group may have the option to cross over and get the Corvia device after 24 months.

Contact Info:

  • Heather Catchpole
  • catchpole.heather@scrippshealth.org
  • 858-824-4248