HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart
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
| Condition(s) | Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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: 1. At least one hospitalization for heart failure within the past 12 months; 2. 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | United Innomed(Shanghai) Limited |
| Locations | Fuzhou, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Guiyang, Guizhou, China; Zhengzhou, Henan, China; Changsha, Hunan, China (+9 more sites) |
| Start date | 2026-03-16 |
| NCT ID | NCT07402239 |
| Official listing | https://clinicaltrials.gov/study/NCT07402239 |