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Device for Heart failure patients with preserved Ejection fraction
In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.
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.
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
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
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.