Trial Number



Heart Failure

Participant Age Range

18 years and older

Participant Gender


Enrolling Participants



Reducing Lung Congestion Symptoms using the V-Wave Shunt in Advanced Heart Failure: RELIEVE-HF

RELIEVE-HF is a global, 500 patient pivotal study of its proprietary, minimally invasive implanted interatrial shunt device for treating patients with NHYA Class III and ambulatory Class IV symptomatic heart failure (HF). This randomized, controlled, double-blinded multicenter clinical trial – the RELIEVE-HF study – will evaluate the safety and effectiveness of V-Wave’s novel device therapy in severe HF patients with either preserved or reduced ejection fraction.


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