Heart Failure With Normal Ejection Fraction Clinical Trial
Official title:
Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial
To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.
The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting. ;
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