HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management

Main Inclusion Criteria：

• Age ≥ 18 years old
• Clinically diagnosed with chronic heart failure
• Receiving guideline directed medical and device therapy (GDMT) for heart failure
• Left ventricular ejection fraction (LVEF) ≤ 40% assessed by echocardiography
• New York Heart Association (NYHA) functional class II or III, with NYHA II criteria met simultaneously; for NYHA III, at least one of the following must be satisfied:

• At least one hospitalization for heart failure within the past 12 months;
• Elevated BNP or NT-proBNP within 3 months prior to enrollment (under normal sinus rhythm, NT-proBNP > 900 pg/mL; under atrial fibrillation, NT-proBNP > 1500 pg/mL; under normal sinus rhythm, BNP > 300 pg/mL; under atrial fibrillation, BNP > 500 pg/mL; BNP not applicable if the patient is using ARNI);
• Able to perform 6-minute walk test (6MWT), with a distance between 100 meters and 450 meters

Main Exclusion Criteria

• Currently in an acute decompensation of chronic heart failure (hospitalization within 2 weeks prior to enrollment), refractory end-stage heart failure, or on the waiting list for heart transplantation (including LVAD indication);
• BMI > 40 kg/m² or < 18.5 kg/m²;
• Systolic blood pressure <90 or ≥160 mmHg
• Moderate or severe aortic or mitral stenosis, or planned during the trial intervention for severe regurgitation of the aortic, mitral, tricuspid, or pulmonary valves;
• Coronary artery disease requiring revascularization;
• Hypertrophic cardiomyopathy, active myocarditis, cardiac tamponade or large pericardial effusion, congenital heart disease, or other causes of heart failure
• History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 3 months
• Severe chronic lung disease requiring oxygen therapy or long-term corticosteroids;
• Surgery involving atrial septal puncture within 3 months before enrollment (e.g., mitral repair, atrial fibrillation ablation, LAA closure);
• Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
• eGFR <25 ml/min/1.73 m^2