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HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT07402239•United Innomed(Shanghai) Limited

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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%
+1 more criteria

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China

Key Dates

Start Date

March 1, 2026

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

February 11, 2026

Enrollment

330

ESTIMATED participants

Conditions

Heart Failure

Interventions

NOVAtria System

DEVICE

Control

OTHER

Contacts

JIANG

CONTACT

+86 0571 87783759 jiangbo@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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