Trial Number
651-26
Condition
Heart Failure
Participant Age Range
18 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“RELIEVE-HFrEF TRIAL: REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure with Reduced EF”
Researchers are studying whether the V-Wave Interatrial Shunt System, a permanently implanted heart device placed during a minimally invasive cardiac catheterization procedure, can reduce heart failure symptoms and hospitalizations in people with advanced heart failure with reduced ejection fraction (HFrEF). The device is designed to decrease pressure in the left side of the heart by allowing blood to flow between the upper chambers of the heart. Participants will be randomly assigned to receive either the shunt device or a control procedure and will be followed for up to three years to evaluate safety, hospitalizations, quality of life, and survival.