An interventional study of NOVAtria System and Control in Heart Failure, sponsored by United Innomed(Shanghai) Limited. Recruiting at 15 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by United Innomed(Shanghai) Limited · Not applicable, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 330 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with United Innomed(Shanghai) Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria：
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:
Main Exclusion Criteria
Treatment arm patients will undergo a right heart catheterization and invasive echocardiography to determine study eligibility and TEE guided trans-septal puncture and NOVAtria® system procedure
Device: NOVAtria System
Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or device implantation
Other: Control
Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and NOVAtria® system procedure
Device: NOVAtria System
The NOVAtria System, therapeutic and monitoring device will be implanted at interatrial septum with minimally invasive cardiac catheterization procedure
Right heart catheterization and TEE
Primary Safety endpoint
Safety-Percentage of Treatment patients experiencing major device-related adverse events.Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
Time frame: 30-days after randomization
Composite Primary Effective endpoint
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in 6WMT
Time frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
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