The objective of the HARMONY trial is to evaluate the safety and efficacy of implantable left atrial pressure sensor and interatrial shunt system for the treatment of chronic heart failure with reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) and New York Heart Association(NYHA) functional Class II or Class III who at baseline are treated with guideline-directed drug and device therapies.
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Primary Safety endpoint
Timeframe: 30-days after randomization
Composite Primary Effective endpoint
Timeframe: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months