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HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
Sponsor: United Innomed(Shanghai) Limited
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
Completion Date
2028-06
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, Zhejiang, China