The Corvia Medical InterAtrial Shunt Device (IASD®) System II is indicated for the improvement in quality of life and reduction of heart failure related symptoms and events in patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard GDMT.
To evaluate the Corvia Medical, Inc. IASD® System II to reduce elevated left atrial pressure in patients with heart failure.
“Currently, there are no common or proven therapies for patients with HFpEF Heart Failure. In this study, we will examine if patients enrolled demonstrate an improvement in functional capacity, quality of life, and reduction of HF symptoms such as shortness of breath and fatigue.” Susan Joseph, MD, principal investigator.
Main/critical inclusion and exclusion criteria: A complete list of inclusion and exclusion criteria for the Reduce LAP-HF Trial II study can be found at: https://clinicaltrials.gov/ct2/show/NCT03088033
Christine Brooks, Christine.Brooks@bswhealth.org, 214.818.2588.