HARMONY: NOVAtria implantable system to monitor and treat chronic heart failure

The Study of a tHerApeutic and monitoRing Device iMplanted at the Atrial Septum prOvides Heart Failure maNagement in sYmptomatic Patients (HARMONY Trial)

This project will test whether an implanted NOVAtria device—a left atrial pressure sensor combined with an interatrial shunt—can help adults with chronic HFrEF (EF ≤40%) and NYHA class II or III who are already on guideline heart-failure medicines.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: United Innomed(Shanghai) Limited (Industry-sponsored)
• Locations: 15 sites (Fuzhou, Fujian and 14 other locations)
• Trial ID: NCT07402239 on ClinicalTrials.gov

What this trial studies

The HARMONY protocol compares an implanted NOVAtria system (left atrial pressure sensor plus interatrial shunt) with a control approach in patients with chronic heart failure and reduced ejection fraction. Enrolled adults receive guideline-directed medical and device therapy and are assigned per protocol to either the NOVAtria intervention or control. Key eligibility includes LVEF ≤40%, NYHA class II–III, and the ability to perform a 6-minute walk test within a specified range; patients are treated and followed at regional Chinese hospitals. Outcomes will focus on device safety, hemodynamic measurements, clinical events, and functional status over the planned follow-up period.

Who should consider this trial

Good fit: Adults (≥18 years) with chronic HFrEF (LVEF ≤40%), NYHA class II or III while on guideline-directed medical and device therapy, and able to walk 100–450 meters on the 6-minute walk test are the ideal candidates.

Not a fit: Patients in acute decompensated heart failure, those with preserved ejection fraction, or those unable to undergo device implantation or perform the 6-minute walk test are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the device could lower left atrial pressure, reduce heart-failure hospitalizations, and improve symptoms and exercise capacity.

How similar studies have performed: Related device-based hemodynamic monitoring (e.g., pulmonary artery sensors) and interatrial shunt approaches have shown promise in prior trials, but combining a left atrial pressure sensor with an interatrial shunt in the NOVAtria system is a newer strategy.

Eligibility criteria

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 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

Where this trial is running

Fuzhou, Fujian and 14 other locations

• Fuzhou University Affiliated Provincial Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Xijing Hospital — Xi’an, Shanxi, China (Not_yet_recruiting)
• West China Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medcine — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)
• The First AFfiliated Hospital of MWU — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, China (Not_yet_recruiting)

Study contacts

• Study coordinator: WANG Jian'an

Conditions Heart Failure