Cordella Investigational device for Heart Failure patients
Thomas Heywood, M.D.
This is a clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in patients with New York Heart Association Class III Heart Failure.
Be at least 18 years of age
Have been diagnosed with NYHA III heart failure and treated for more than 3 months
Be on stable, optimally titrated medical therapy for at least 30 days
Have had a heart failure hospitalization within 12 months
Patients must not:
Have a history of recurrent pulmonary embolism
Have unrepaired severe valvular disease
Have a history of life threatening allergy to contrast dye
Study participants will receive the investigational Cordella PA Sensor System Implant. All treatments and physician visits will take place at Anderson Medical Pavilion. Follow-up visits will occur at 1, 3, 6, 12, 18, and 24 months and year 3 after the implant procedure.