NOVAtria System: The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure
Control: Right heart catheterization and TEE
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Primary Safety endpoint — 30-days after randomization Safety-Percentage of Treatment patients experiencing major device-related adverse events.Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
Composite Primary Effective endpoint — Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in 6WMT
Trial sites (15)
Facility
City
Region
Status
Fuzhou University Affiliated Provincial Hospital
Fuzhou
Fujian
Not Yet Recruiting
The First Hospital of Lanzhou University
Lanzhou
Gansu
Not Yet Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Not Yet Recruiting
Guizhou Provincial People's Hospital
Guiyang
Guizhou
Not Yet Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou
Henan
Not Yet Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Hunan
Not Yet Recruiting
Xiangya Hospital of Central South University
Changsha
Hunan
Not Yet Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
Shanghai Chest Hospital
Shanghai
Shanghai Municipality
Not Yet Recruiting
Xijing Hospital
Xi’an
Shanxi
Not Yet Recruiting
West China Hospital
Chengdu
Sichuan
Not Yet Recruiting
The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou
Zhejiang
Recruiting
The First Affiliated Hospital of Ningbo University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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