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Clinical Trials in China / NCT07402239
Recruiting Not applicable

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

NCT07402239 · tracked via the Priya Life Science China tracker
Sponsor
United Innomed(Shanghai) Limited
Phase
Not applicable
Started
2026-03-16
Last updated
2026-05-08

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

NOVAtria SystemControl

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)

Trial sites (15)

FacilityCityRegionStatus
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 Ningbo Zhejiang Not Yet Recruiting
The First AFfiliated Hospital of MWU Wenzhou Zhejiang Not Yet Recruiting
Sichuan Provincial People's Hospital Chengdu China Not Yet Recruiting

Other trials for the same condition

Official registry record

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.

View NCT07402239 on ClinicalTrials.gov ↗ ← All trials in China