The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.
Protocol Amendment History
60 amendments
This ClinicalTrials.gov record has been amended 60 times since 2018-04-13; most recent amendment 2025-08-18.
Status change: Recruiting → Active, Not Recruiting2022-10-26
Status change: Not Yet Recruiting → Recruiting2018-10-01