Currently Enrolling Patients in RELIEVE-HF 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.
- 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.