Tests the NOVAtria device in adults with heart failure
Tests an implanted heart device in adults with heart failure and reduced pumping strength.
Plain-language title generated from the registry record
Registry title: HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
Key facts
- Where
- Changsha, Chengdu, Fuzhou, Guangzhou, Guiyang, Hangzhou, Lanzhou, Nanchang, Ningbo, Shanghai, Wenzhou, Xi'an, and Zhengzhou, ChinaSee the 15 sites
Where in China
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- Sichuan Provincial People's HospitalChengdu, ChinaNot yet recruiting
- West China HospitalChengdu, ChinaNot yet recruiting
- Fuzhou University Affiliated Provincial HospitalFuzhou, ChinaNot yet recruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaNot yet recruiting
- Guizhou Provincial People's HospitalGuiyang, ChinaNot yet recruiting
- The Second Affiliated Hospital Zhejiang University School of MedcineHangzhou, ChinaTaking people
- The First Hospital of Lanzhou UniversityLanzhou, ChinaNot yet recruiting
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaNot yet recruiting
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaNot yet recruiting
- Shanghai Chest HospitalShanghai, ChinaNot yet recruiting
- The First AFfiliated Hospital of MWUWenzhou, ChinaNot yet recruiting
- Xijing hospitalXi'an, ChinaNot yet recruiting
- Fuwai Central China Cardiovascular HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- United Innomed(Shanghai) Limited
- Trial code
- NCT07402239
- Record updated
- 8 May 2026
- Original description
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.Read full original descriptionShow less
The Study of a tHerApeutic and monitoRing Device iMplanted at the Atrial Septum prOvides Heart Failure maNagement in sYmptomatic Patients (HARMONY Trial)
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.
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.