Are you living with heart failure? You may be eligible for a clinical trial.

The Texas Heart Institute Center for Clinical Research is conducting a randomized study with the objective to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving clinical outcomes in patients with a NYHA heart failure classification of II-IV, irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies. The shunt is placed in the septum between the right and left atria of the heart. A small opening allows a small amount of blood to flow from the left to the right atria which decrease pressure on the left side of the heart reducing congestion in the lungs.

Title: RELIEVE-HF TRIAL: REducing Lung congestIon symptoms using the V-wavE shunt in adVancEd Heart Failure

PI: Zvonimir Krajcer, MD
Sponsor: V-Wave, Ltd.

NCT03499236

Eligibility Requirements

• Heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
• NYHA Class II, Class III, or ambulatory Class IV heart failure
• Receiving guideline-directed medical and device therapy (GDMT) for heart failure
• Prior hospitalization for heart failure within the last year and or elevated BNP or NT-proBNP level.

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