RecruitingNot ApplicableNCT07402239

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)


Sponsor

United Innomed(Shanghai) Limited

Enrollment

330 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the NOVAtria System — a device designed to monitor and manage chronic heart failure — in people whose hearts pump with reduced strength. Researchers want to see if it is safe, effective, and improves quality of life. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with chronic heart failure - Your heart pumps at 40% or less of its normal capacity (reduced ejection fraction) - You are in New York Heart Association (NYHA) functional class II or III — meaning you have symptoms during moderate or minimal activity - You are already on recommended heart failure medications and/or devices **You may NOT be eligible if...** - You have very severe heart failure (NYHA class IV — symptoms at rest) - You have a recent major cardiac event (heart attack, surgery) in the past 3 months - You have a mechanical heart valve or other implants that interfere with the device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENOVAtria System

The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure

OTHERControl

Right heart catheterization and TEE


Locations(1)

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China

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NCT07402239


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