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RECRUITING
NCT07402239
NA

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2026-03-16

Completion Date

2028-06

Last Updated

2026-05-08

Healthy Volunteers

No

Conditions

Interventions

DEVICE

NOVAtria System

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

OTHER

Control

Right heart catheterization and TEE

Locations (15)

Fuzhou University Affiliated Provincial Hospital

Fuzhou, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Xijing Hospital

Xi’an, Shanxi, China

West China Hospital

Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

The First AFfiliated Hospital of MWU

Wenzhou, Zhejiang, China

Sichuan Provincial People's Hospital

Chengdu, China